Current jobs related to Director, Global Regulatory Strategy - Jackson - Pfizer, S.A. de C.V
-
Jackson, Mississippi, United States Agilent Technologies Full time{"title": "Senior Director, Customer Experience and Market Strategy", "subtitle": "Drive Customer-Centric Growth at Agilent Technologies", "content": "Agilent Technologies is seeking a Senior Director, Customer Experience and Market Strategy to lead our global segment marketing and customer experience efforts. As a key member of our commercial organization,...
-
Director of Debt Resolution and Strategy
3 weeks ago
Jackson, Mississippi, United States Travelers Insurance Full timeAbout the RoleWe are seeking a highly skilled and experienced Managing Director to lead our Medicare operations and drive strategic initiatives to resolve debt and improve financial outcomes.Key ResponsibilitiesDevelop and direct comprehensive strategies for addressing and resolving various types of debt, including Medicare, to deliver positive financial...
-
GTM Strategy Director
1 week ago
Jackson, Mississippi, United States Verint Systems Full timeAbout the RoleVerint Systems is seeking a seasoned professional to lead our Go-To-Market Strategy efforts for our Recording and EDM portfolio. As the Director of Go-To-Market Strategy, you will be responsible for driving business growth, developing go-to-market strategies, and building tools, messaging, and sales enablement materials to support market...
-
Director, Sales Strategy
2 months ago
Jackson, United States SYSCO Full timeCompany: US6469 Sysco Payroll, Division of Sysco Resources Services, LLC Zip Code: 53037 Minimum Level of Education: Bachelor’s Degree Minimum Years of Experience: 10+ Years Employment Type: Full Time Travel Percentage: 0 COMPENSATION INFORMATION: The pay range provided is not indicative of Sysco’s actual pay range but is merely...
-
Director, Sales Strategy
4 weeks ago
JACKSON, United States Sysco Full timeCompany: US6469 Sysco Payroll, Division of Sysco Resources Services, LLCZip Code:53037Minimum Level of Education:Bachelor’s DegreeMinimum Years of Experience:10+ YearsEmployment Type:Full TimeTravel Percentage: 0COMPENSATION INFORMATION:The pay range provided is not indicative of Sysco’s actual pay range but is merely algorithmic and provided for...
-
Jackson, Mississippi, United States Saxon Global Full timeAbout the RoleSaxon Global is seeking a highly experienced and skilled Director of Operations and Manufacturing Excellence to lead our manufacturing operations and drive continuous improvement initiatives. As a key member of our leadership team, you will be responsible for ensuring the efficient and effective operation of our manufacturing facilities, while...
-
Jackson, Mississippi, United States Saxon Global Full timeAbout the RoleSaxon Global is seeking a highly experienced and skilled Director of Operations and Manufacturing Excellence to lead our manufacturing operations and drive continuous improvement initiatives. As a key member of our leadership team, you will be responsible for overseeing all aspects of plant operations, including production planning, quality...
-
Director of Growth Strategy and Operations
1 week ago
Jackson, Mississippi, United States Imagen Technologies Full time{"title": "Director of Growth Strategy and Operations", "content": "Join Imagen Technologies as a Director of Growth Strategy and OperationsAt Imagen Technologies, we're revolutionizing healthcare by enabling patients to receive immediate diagnostic tests, results, and next steps in a single primary care appointment. Our AI-enabled platform is rapidly...
-
Jackson, Mississippi, United States Saxon Global Full timeAbout the RoleSaxon Global is seeking a highly experienced and skilled Director of Operations and Manufacturing Excellence to lead our manufacturing operations and drive continuous improvement initiatives. As a key member of our leadership team, you will be responsible for ensuring the efficient and effective operation of our manufacturing facilities, while...
-
Enterprise Medical Director
1 week ago
Jackson, Mississippi, United States CareSource Full timeJob Summary:The Enterprise Medical Director is a key leadership position responsible for driving the development, implementation, and revision of corporate-level clinical care standards and practice guidelines. This role ensures compliance with nationally accepted quality standards, promoting excellence in patient care and outcomes.Key...
-
Director Quality Improvement
1 week ago
Jackson, United States Consumers Energy Full timeGeneral Summary: The Director Quality Improvement is responsible for the planning, coordination, and execution of the Lean operating system and continuous improvement project focuses for Consumers Energy (CE). They work closely with the CEO and other members of the executive team to develop and implement the company's lean & continuous improvement...
-
Strategic Director
3 weeks ago
Jackson, Mississippi, United States Grades of Green Full timeJob DescriptionExecutive DirectorGrades of Green is seeking a seasoned professional to serve as its Executive Director. This key role will provide strategic leadership to the organization, overseeing day-to-day operations and ensuring the fulfillment of our mission and goals.The Executive Director will be responsible for managing staff, overseeing...
-
Jackson, Mississippi, United States CVS Health Full timeCVS Health Lead Director OpportunityCareers at CVS Health are more than just a job - they're a way to make a meaningful difference in the lives of millions of people. As a Lead Director at CVS Health, you will play a critical role in shaping the future of pharmacy and pharmaceutical development.Job SummaryThe Lead Director will be responsible for developing...
-
Senior Compliance Analyst for Global Trade
4 weeks ago
Jackson, Mississippi, United States Desktop Metal Full timeCompany Overview:Desktop Metal is at the forefront of revolutionizing additive manufacturing technologies aimed at producing end-use components. We provide a comprehensive suite of integrated solutions for engineers, designers, and manufacturers, encompassing hardware, software, materials, and services.Role Summary:The Senior Compliance Analyst for Global...
-
Lead Regulatory Auditor
4 weeks ago
Jackson, Mississippi, United States State of Mississippi Full timeSalary: $51, $88,201.89 AnnuallyLocation: Hinds County, MSJob Type: Full-TimeDepartment: Public Utilities StaffAbout the Agency: The Mississippi Public Utilities Staff ("MPUS") is an Executive Agency dedicated to safeguarding the interests of the State of Mississippi. This agency plays a crucial role in balancing the concerns of residential, commercial, and...
-
Director of Operations
2 weeks ago
Jackson, Mississippi, United States Saxon Global Full timeESSENTIAL QUALIFICATIONS: * Proficient in ERP systems (preferably Oracle) - Background in sheet metal production and assembly - Apply Lean Six Sigma and Theory of Constraints methodologies to foster ongoing enhancements - Proven track record in leading large teams towards sustained improvements. - In-depth understanding of continuous improvement...
-
Medical Director Opportunity in Jackson, TN
5 days ago
Jackson, Tennessee, United States Premier Anesthesia Full timeMedical Director OpportunityPremier Anesthesia is seeking a highly skilled Medical Director to lead our team in Jackson, TN.Key Responsibilities:Provide exceptional leadership and guidance to our anesthesia teamDevelop and implement strategies to improve patient care and outcomesCollaborate with hospital administrators to ensure seamless integration of our...
-
Global Supply Chain Director
1 week ago
Jackson, Mississippi, United States Paxcbd Full time{"title": "VP of Operations, Global Supply and Demand", "company": "PAX", "description": "Job SummaryWe are seeking a highly experienced and strategic leader to join our team as VP of Operations, Global Supply and Demand. As a key member of our leadership team, you will be responsible for overseeing our global supply chain and demand planning operations,...
-
Field Service Technician
2 weeks ago
Jackson, Mississippi, United States Talent Strategy Full timeJob SummaryWe are seeking a highly skilled Field Service Technician to join our team at Talent Strategy. As a key member of our service team, you will be responsible for providing exceptional customer service and support during field visits, ensuring maximum efficiency and productivity.Key ResponsibilitiesCustomer Service and Support: Provide top-notch...
-
Director of Quality Assurance
1 week ago
Jackson, Tennessee, United States Wabtec Corporation Full timeJob SummaryWe are seeking a highly skilled and experienced Director of Quality Assurance to join our team at Wabtec Corporation. The successful candidate will be responsible for leading the Quality Assurance Process, ensuring quality products and processes, and establishing and enforcing quality standards.Key ResponsibilitiesQuality Assurance Leadership:...
Director, Global Regulatory Strategy
4 months ago
United States - New York - New York City
United States - Pennsylvania - Collegeville
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the
ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines
.
What You Will Achieve
You will represent Pfizer as an
A
pproval
L
iaison in the regulatory affairs team. You will play the critical role of p
roviding strategic regulatory expertise as Global regulatory representative to Product Team(s).
As a Director, Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from North America, Europe, Emerging Markets, Japan.
Through the GRST, develop, align, manage and implement the global regulatory strategy.
Be accountable for:
Delivering the project goals and aligning the regulatory strategy with global and business regional needs.
Timely submissions and approvals with commercially attractive labelling across the regions.
Ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s).
Role may be combined with other Regulatory Role (i.e. regional US or EU regulatory role and/or Regulatory Lead for other projects).
Project(s) assigned could be in development and/or at post-authorization stage.
How You Will Achieve It
Responsible for the production, updating and communication of global regulatory strategies for assigned projects/ products, mechanisms of action and/or indications.
Provides regulatory expertise and leadership for the project/product.
Member of appropriate Project(s)/Product(s) teams.
In partnership with the Project/Product Team Leader (eg MTL, GCMTL, RPL etc.), accountable for the delivery of the Project/product goals according to the endorsed Global Regulatory Strategy.
Ensures appropriate representation for Pfizer for the project/product with Health Authorities.
Ensures rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues.
Ensures that all regulatory development process commitments are clearly communicated, monitored and met.
Acts as the point of contact for all internal Pfizer communication regarding the status of the project/product on issues related to regulatory process and registration strategy
Mentoring, developing regulatory professionals who are assisting in meeting the project/product objectives.
Develop strong and positive working relationships with regulators, professional bodies, external experts, opinion leaders and Pfizer internal and external stakeholders.
Ensures rapid reporting of key project/product regulatory milestones and/or issues to the GRPL and other stakeholders as required.
Participates in appropriate governance committees, as necessary.
Qualifications
Must-Have
Bachelor's Degree
(BA/BS)and 10+ years of experience . MS, PharmD, PhD or MD preferred. Equivalent workplace experience can be considered.
Extensive direct regulatory experience, preferably including as a Global Regulatory Lead and leading a GRST.
Advanced knowledge of US FDA and/or EU regulations.
Working knowledge of other regulations and their associated challenges for global development programs.
Direct experience with at least US and/or EU submissions and approvals.
Direct experience in communicating with major regulatory agency(ies) (ie FDA, EMA, Japan), as well as participating in/leading such interactions such as End-of-Phase 2, pre-submission meeting(s).
Understanding of clinical trial design and management, including data flow process.
Experience working in a highly matrixed, global and multi-site environment.
Track record of having supported at least one project of high complexity and provided strategic direction.
Experience within different therapeutic areas and at different stages of products life cycle.
Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations
Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
Presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior managers.
Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations.
Work Location Assignment:Onsite/Hybrid
Why Patients Need You
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the
ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines
.
What You Will Achieve
You will represent Pfizer as an
A
pproval
L
iaison in the regulatory affairs team. You will play the critical role of p
roviding strategic regulatory expertise as Global regulatory representative to Product Team(s).
As a Director, Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from North America, Europe, Emerging Markets, Japan.
Through the GRST, develop, align, manage and implement the global regulatory strategy.
Be accountable for:
Delivering the project goals and aligning the regulatory strategy with global and business regional needs.
Timely submissions and approvals with commercially attractive labelling across the regions.
Ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s).
Role may be combined with other Regulatory Role (i.e. regional US or EU regulatory role and/or Regulatory Lead for other projects).
Project(s) assigned could be in development and/or at post-authorization stage.
How You Will Achieve It
Responsible for the production, updating and communication of global regulatory strategies for assigned projects/ products, mechanisms of action and/or indications.
Provides regulatory expertise and leadership for the project/product.
Member of appropriate Project(s)/Product(s) teams.
In partnership with the Project/Product Team Leader (eg MTL, GCMTL, RPL etc.), accountable for the delivery of the Project/product goals according to the endorsed Global Regulatory Strategy.
Ensures appropriate representation for Pfizer for the project/product with Health Authorities.
Ensures rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues.
Ensures that all regulatory development process commitments are clearly communicated, monitored and met.
Acts as the point of contact for all internal Pfizer communication regarding the status of the project/product on issues related to regulatory process and registration strategy
Mentoring, developing regulatory professionals who are assisting in meeting the project/product objectives.
Develop strong and positive working relationships with regulators, professional bodies, external experts, opinion leaders and Pfizer internal and external stakeholders.
Ensures rapid reporting of key project/product regulatory milestones and/or issues to the GRPL and other stakeholders as required.
Participates in appropriate governance committees, as necessary.
Qualifications
Must-Have
Bachelor's Degree
(BA/BS)and 10+ years of experience . MS, PharmD, PhD or MD preferred. Equivalent workplace experience can be considered.
Extensive direct regulatory experience, preferably including as a Global Regulatory Lead and leading a GRST.
Advanced knowledge of US FDA and/or EU regulations.
Working knowledge of other regulations and their associated challenges for global development programs.
Direct experience with at least US and/or EU submissions and approvals.
Direct experience in communicating with major regulatory agency(ies) (ie FDA, EMA, Japan), as well as participating in/leading such interactions such as End-of-Phase 2, pre-submission meeting(s).
Understanding of clinical trial design and management, including data flow process.
Experience working in a highly matrixed, global and multi-site environment.
Track record of having supported at least one project of high complexity and provided strategic direction.
Experience within different therapeutic areas and at different stages of products life cycle.
Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations
Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
Presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior managers.
Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations.
The annual base salary for this position ranges from $161,600.00 to $269,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Regulatory Affairs
#J-18808-Ljbffr
