Current jobs related to Senior Manager, Regulatory Affairs CMC - Collegeville - Pfizer
-
Regulatory Affairs Manager
8 hours ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeJob SummaryWe are seeking a highly motivated and experienced Regulatory Affairs professional to join our Small Molecules Development Projects CMC Regulatory Affairs Group as a Regulatory Affairs Manager - Chemistry, Manufacturing and Controls (CMC).Key ResponsibilitiesManage global CMC regulatory activities, from early phase clinical through marketing...
-
Director, Global Regulatory Affairs, Vaccines
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeJob SummaryWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at GlaxoSmithKline as a Director, Global Regulatory Affairs, Vaccines. This role will be responsible for ensuring the development and execution of regulatory strategies for assigned US assets, across all stages of the product life cycle.Key...
-
Senior Manager, GRA, CMC Vx Mature Products
2 weeks ago
Collegeville, United States GlaxoSmithKline Full timeSite Name: Belgium-Wavre, Poznan Grunwaldzka, UK - London - New Oxford Street, USA - Maryland - Rockville, USA - Pennsylvania - Upper ProvidencePosted Date: Sep 16 2024Senior Manager, CMC Vaccines Mature Products (Global Regulatory Affairs)Job purpose Lead CMC regulatory activities in the late development and /or lifecycle management of GSK products In this...
-
Regulatory Affairs Director
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeJob PurposeAs a key member of the GlaxoSmithKline team, the successful candidate will be responsible for developing and executing regional regulatory strategies that align with the company's Medicines Development Strategy. This will involve working closely with cross-functional teams to ensure compliance with internal processes and regional regulatory...
-
Scientific Writer- Regulatory
4 weeks ago
Collegeville, United States Thermo Fisher Scientific Full timeWork ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionThermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.Within our...
-
Director of Regulatory Policy and Advocacy
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly experienced and motivated Director of Regulatory Policy and Advocacy to join our dynamic team at GlaxoSmithKline. This role will be pivotal in shaping and influencing regulatory policies related to Chemistry, Manufacturing, and Controls (CMC) on a global scale, with a particular focus on supporting our growing digital,...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled Senior Manager to lead our Chemical Development and Optimization team at GlaxoSmithKline. As a key member of our organization, you will be responsible for the development, optimization, implementation, and management of robust, cost-effective, and safe processes for the manufacture of small molecules, including...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timePosition Overview:The Senior Vice President of Clinical Research Initiatives will spearhead the strategic development, innovation, execution, and oversight of all interventional clinical trials within the medical affairs division. This includes the formulation and implementation of a comprehensive portfolio of medical affairs-sponsored Phase IV studies.This...
-
Senior Publications Manager
4 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timePosition Overview:The Global/Regional Publications Senior Manager will spearhead the development of Strategic Publications Plans that align with the overarching medical communication strategy and objectives for specific assets, ensuring coherence with the established publication strategy at the asset and regional levels. In this capacity, the Senior Manager...
-
Director, Medical Affairs Oncology Digital
1 month ago
Collegeville, United States Pfizer Full timeROLE SUMMARY The Director, Medical Affairs Oncology Digital & AI Innovation will report to the Oncology AI Innovation Head. This is a vital role within the Pfizer Oncology organization, acting as an operational business partner across Oncology Medical, International Medical Affairs, and Pfizer US (Medical Platforms) for all digital and AI...
-
Sr. Manager, Clinical Scientist, Vaccines
3 weeks ago
Collegeville, United States Pfizer Full timeROLE SUMMARYThe Clinical Scientist (CS) - Sr. Manager will support clinical epidemiology study execution for multiple studies for one or more vaccine programs. In collaboration with Scientific Affairs (SA) / Clinical Epidemiology, Biostatistics group and Clinical Affairs (CA) Operations, the CS is responsible for execution and project management of their...
-
Project Director
1 week ago
Collegeville, United States ETeam Inc Full timeThese individuals must have a scientific background in either a CMC discipline (i.e., Supply Chain, Drug Substance, Drug Product or Analytical) or safety/DMPK within the pharmaceutical industry.Does this person have experience working on CMC (Chemistry Manufacturing and Control) or Safety/DMPK aspects of pharmaceutical products as a workstream/technical...
-
Collegeville, United States Pfizer Full timeROLE SUMMARY •The overall role of the Oncology Early Stage [OES] Clinical Scientist (Senior Manger, non-MD) is to work collaboratively with the Global Development Lead (and members of the development team) to establish, lead, coordinate, and execute the early oncology clinical development plan(s) for one or more novel biological or small molecule...
-
Senior Manager, Resource Planning
4 weeks ago
Collegeville, United States Pfizer Full timeThe Senior Manager, Resource Planning and Management delivers business operations and resource management support services in support of the Pfizer Oncology Division (POD). Also responsible for contributing to the achievement of POD's business strategies and goals by partnering with applicable business/resource managers and senior leaders across POD and...
-
Senior Product Manager
4 weeks ago
Collegeville, United States Alphanumeric Systems Inc. Remote Work Freelance Full time $82 - $86Alphanumeric is hiring a Senior Product Manager, Data Governance Products to work in Collegeville, PA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.POSITION TITLE: Senior Product Manager, Data Governance ProductsHOURLY PAY: $86.75DURATION: Through the end of 2024100% REMOTE - Candidate must be...
-
Associate Director of Analytical Development
15 hours ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeJob SummaryWe are seeking a highly skilled and experienced Associate Director of Analytical Development to lead our team of analytical scientists in the development, manufacturing, release, and stability testing of drug substances and drug products. The successful candidate will have a strong background in analytical chemistry and pharmaceutical industry...
-
Senior Budget Manager
3 weeks ago
Collegeville, Pennsylvania, United States InsideHigherEd Full timeAbout the RoleThe Director of Budget and Planning will play a pivotal role in leading the college's procurement processes, comprehensive budget management activities, and long-term financial planning. This executive position is responsible for developing and implementing strategic procurement initiatives, optimizing purchasing practices, managing vendor...
-
Director of Health
1 month ago
Collegeville, United States Morningside House Senior Living Full timeJob DescriptionJob DescriptionNow Hiring: Director of Health & Wellness, LPNWe are looking for a Director of Health & Wellness, LPN to join our leadership team at Morningside House of Collegeville, a leading personal care and memory care community in Collegeville, PA.Apply today to become a valued member of our incredible team at Morningside House Senior...
-
Senior DMPK Project Specialist
10 hours ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeJob Title: Senior DMPK Project SpecialistGlaxoSmithKline is seeking a highly skilled Senior DMPK Project Specialist to join our team. As a key member of our DMPK organization, you will be responsible for providing scientific expertise and support to our development projects.Key Responsibilities:Provide DMPK input into project strategy and data interpretation...
-
Director of Health and Wellness
3 weeks ago
Collegeville, United States Morningside House Senior Living Full timeJob DescriptionJob DescriptionNow Hiring: Director of Health & Wellness, LPNWe are looking for a Director of Health & Wellness, LPN to join our leadership team at Morningside House of Collegeville, a leading personal care and memory care community in Collegeville, PAApply today to become a valued member of our incredible team at Morningside House Senior...
Senior Manager, Regulatory Affairs CMC
4 months ago
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.
What You Will Achieve
You will help Pfizer develop and implement chemistry, manufacturing and controls (CMC) regulatory strategies for small and/or large molecules to meet global regulatory requirements throughout the life cycle. You will participate in a variety of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post-approval submissions, representing the company on communications and in meetings with health authorities, assessing impact of new regulations, managing regulatory documents, etc. You will also be in a position to negotiate with regulatory authority personnel to expedite approval of pending registrations and respond to queries.
As a Senior Manager, your advanced knowledge of the principles and concepts in the area of regulatory affairs and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets. Your ability to develop and manage plans will facilitate achieving objectives, interpreting internal and external business challenges, and recommending best practices for improvements.
It is your leadership skills that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Develop ideas and lead/co-lead complex projects across division, and develop and manage plans to achieve objectives.
Ensure regulatory conformance & consistency globally in compliance with external regulatory requirements and internal quality procedures.
Investigate opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.
Develop effective relationships with local & global internal partners, i.e., Research and Development, Pfizer Global Supply, Global Regulatory Sciences, Business Units, etc.
Serve as a Global Regulatory Sciences Chemistry Manufacturing and Controls (CMC) strategist and project leader, providing regulatory assessments and developing regulatory strategies with minimal supervision.
Lead the preparation of CMC information for submission to regulatory agencies, generate CMC strategies, assess risks and develop contingency plans, including major, complex applications.
Execute training-related activities (e.g. compliance-related, HR policies) and individual development plans, participate in cross-disciplinary forums & learning opportunities.
Demonstrate and model adherence to all Pfizer behaviors & values, embrace and comply with Global Chemistry Manufacturing and Controls Principles of Integrity.
Serve as a technical and scientific resource within own work group and provide guidance for completion of difficult and complex projects.
Qualifications
Must-Have
Bachelor's Degree
7+ years of experience in the pharmaceutical industry
3+ years of pharmaceutical regulatory experience
Drug substance or drug product development or manufacturing technical support experience
Experience in regulatory Chemistry Manufacturing and Controls (CMC) or regulatory expertise in pharmaceutical science development and/or manufacturing
Solid understanding of the regulatory requirements and expectation, criteria for submission and approval globally, and experience with regulatory authority interactions
Demonstrated commitment and dedication to scientific & regulatory integrity and to quality compliance
Ability to learn and navigate tracking/change control systems, and willingness to train and support others in system use
Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities
Strong interpersonal and leadership skills
Competent working knowledge of computer-based systems, such as Microsoft Office and controlled documentation systems
Nice-to-Have
Master's degree
Experience engaging in the external regulatory and pharmaceutical environment
2+ years of hands-on CMC authoring experience (investigational, initial registrations or post-approval)
3+ years of management/supervisory experience
Experience managing projects
Breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PHYSICAL/MENTAL REQUIREMENTS
This position/role works in an office where physical requirements are consistent with typical office functions & activities. This position must also be affiliated with a Pfizer facility.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This role is expected to travel domestically & internationally as required.
The external environment is dynamic & may require flexibility outside of conventional working hours and on weekends to support project timelines.
PHYSICAL/MENTAL REQUIREMENTS
This position/role works in an office where physical requirements are consistent with typical office functions & activities. This position must also be affiliated with a Pfizer facility.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This role is expected to travel domestically & internationally as required.
The external environment is dynamic & may require flexibility outside of conventional working hours and on weekends to support project timelines.
Work Location Assignment: On premise
The annual base salary for this position ranges from $131,200.00 to $218,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% 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
#LI-PFE
