Current jobs related to Senior Director, Regulatory Affairs - Florham Park - Shionogi Inc.
-
Regulatory Affairs Senior Associate/Manager
4 weeks ago
Florham Park, New Jersey, United States Exeltis Full timeJob OverviewPosition Summary:As a key member of the Regulatory Affairs team, you will take on the role of Regulatory lead, overseeing submission planning and strategy for both developmental initiatives and existing FDA-approved products. Your expertise will be crucial in preparing high-quality ANDA submissions, including amendments, supplements, and Annual...
-
Regulatory Affairs Senior Associate/Manager
4 weeks ago
Florham Park, New Jersey, United States Exeltis Full timeJob OverviewPosition Title: Senior Associate/Manager, Regulatory AffairsSalary: CompetitiveRole Summary:In this position, you will take on the role of Regulatory lead, overseeing submission planning and strategy for both development initiatives and currently approved products. Your primary responsibility will be to prepare high-quality ANDA submissions,...
-
Senior Associate/Manager, Regulatory Affairs
2 months ago
Florham Park, United States Exeltis Full timeJob DescriptionJob DescriptionSalary: Role Overview In this role, you will be a Regulatory lead for submission planning and submission strategy for development projects and existing (FDA Approved) products. You will be expected to prepare high quality ANDA submissions (including amendments, supplements and Annual Reports) with the support and oversight of...
-
Regulatory Affairs Senior Associate/Manager
4 weeks ago
Florham Park, New Jersey, United States Exeltis Full timeJob OverviewSalary: CompetitiveRole Summary:In this position, you will take on the role of Regulatory lead, focusing on submission planning and strategy for both development initiatives and currently marketed products. Your responsibilities will include the preparation of high-quality ANDA submissions, including amendments, supplements, and Annual Reports,...
-
Menlo Park, United States Meet Full timeSenior Director, Regulatory Affairs - Advertising and Promotion*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Director of Regulatory Affairs,...
-
Menlo Park, United States Meet Full timeSenior Director, Regulatory Affairs - Advertising and Promotion*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Director of Regulatory Affairs,...
-
Director Regulatory Affairs
4 weeks ago
Abbott Park, United States Abbott Laboratories Full timeWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:Career development with an international company where you can grow the career you dream ofFree medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent...
-
Director Regulatory Affairs
4 weeks ago
Abbott Park, United States Abbott Laboratories Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...
-
CMC Regulatory Affairs Specialist
1 week ago
Florham Park, New Jersey, United States Clinical Resource Network (CRN) Full timeCMC Regulatory Affairs Manager Job DescriptionOur client, a leading pharmaceutical company, is seeking a highly skilled CMC Regulatory Affairs Manager to join their team. This is a hybrid role based out of the Florham Park office, offering a unique blend of on-site and remote work.Key Responsibilities:Manage the full lifecycle of approved New Drug...
-
Regulatory Affairs Strategy Director
2 weeks ago
Franklin Park, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timeJob SummarySun Pharmaceutical Industries, Inc. is seeking a highly experienced and skilled Regulatory Affairs Strategy Director to provide strategic leadership for the company's regulatory affairs and novel drug development programs.Key ResponsibilitiesDevelop and execute the overall regulatory strategy for novel drug development programs, including...
-
CMC Regulatory Affairs Manager
4 weeks ago
Florham Park, United States Clinical Resource Network (CRN) Full timeOur client is looking to fill the role of CMC Regulatory Affairs. This position will be hybrid and based out of the Florham Park office.Salary: $140-150kResponsibilities:Full lifecycle management of approved NDAsPreparing and submitting NDA annual reports, post-approval CMC supplementsSubmission activities in eCTD formatProvide regulatory assessments of CMC...
-
Menlo Park, California, United States Corcept Therapeutics Full timeAbout the RoleCorcept Therapeutics is seeking a highly skilled Director of Medical Writing and Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for leading the development of high-quality, strategically aligned medical writing deliverables that support our clinical development programs.This is...
-
Litchfield Park, Arizona, United States Liberty Utilities Full timeJob SummaryAs a Senior Manager of Rates and Regulatory Affairs at Liberty Utilities, you will play a pivotal role in collaborating with the Transformation and Regulatory Teams to drive the success of rate case filings across multiple states and commodities. Reporting to the Senior Director, Rates & Regulatory Affairs, you will be instrumental in preparing...
-
CMC Regulatory Affairs Manager
2 weeks ago
Florham Park, New Jersey, United States Clinical Resource Network (CRN) Full timeAbout the RoleWe are seeking a highly skilled CMC Regulatory Affairs Manager to join our team at Clinical Resource Network (CRN). As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and guidelines related to CMC (Chemistry, Manufacturing, and Controls) in the pharmaceutical industry.Key...
-
Director of Regulatory Affairs
4 months ago
Winter Park, United States Full Sail University Full timeIf you're looking for the chance to learn, grow, and make a contribution to the community, look at employment opportunities with Full Sail University. You'll find your choice of career opportunities, great benefits, an environment that welcomes and values creativity, and a work experience that is both challenging and rewarding!This position will...
-
Senior Manager, Rates and Regulatory Affairs
4 months ago
Litchfield Park, United States Liberty Utilities Full timePurpose As our Senior Manager of Rates and Regulatory Affairs you will collaborate with the Transformation and Regulatory Teams, contributing to the success of rate case filings across multiple states and commodities. Reporting to the Senior Director, Rates & Regulatory Affairs, you will be instrumental in preparing regulatory materials and supporting...
-
Florham Park, New Jersey, United States Shionogi Inc. Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Medical Director to lead our Virology and COVID-19 therapeutic area team at Shionogi Inc. This is a critical role that requires a strong medical background, excellent leadership skills, and the ability to communicate complex scientific information effectively.Key ResponsibilitiesMedical...
-
Florham Park, New Jersey, United States Shionogi Inc. Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Medical Director to lead our Virology and COVID-19 therapeutic area team at Shionogi Inc. This is a critical role that requires a strong medical background, excellent leadership skills, and the ability to communicate complex scientific information effectively.Key ResponsibilitiesMedical...
-
Florham Park, New Jersey, United States Shionogi Inc. Full timeJob SummaryShionogi Inc. is seeking a highly experienced and skilled Senior Medical Director to lead our Virology and COVID-19 Medical Affairs team. As a key member of our Medical Affairs organization, you will be responsible for providing medical/scientific support for relevant Shionogi products and serving as a medical subject matter expert.Key...
-
Strategic Scientific Director, Medical Affairs
3 weeks ago
Florham Park, New Jersey, United States AbbVie Full timeJob SummaryThe Medical/Scientific Director, Medical Affairs - Psychiatry Pipeline is a key role within AbbVie's R&D organization, responsible for developing and executing medical strategies to advance pipeline assets in the psychiatry space.Key ResponsibilitiesDevelop and execute comprehensive medical affairs strategies to secure insights, develop scientific...
Senior Director, Regulatory Affairs
3 months ago
Overview:
The Senior Director, Regulatory Affairs - GDP provides strategic oversight and direction for regulatory activities on a regional and/or global scale. This role entails leading a multidisciplinary team in developing and executing regulatory strategies to advance our vaccine and bacterial product portfolio through all stages of development and commercialization within specific regions, such as the US. Responsibilities include developing and implementing regulatory strategy, driving regulatory submissions, fostering collaboration with regional regulatory authorities, managing regulatory risks and opportunities, and providing strategic guidance to executive and senior leadership. The Senior Director will serve as a key advisor on regulatory matters, ensuring alignment with company goals, regional requirements, and best practices to achieve successful outcomes for our products in targeted markets.
Responsibilities:- Develop and execute regional regulatory strategies to support the development, registration, and commercialization of vaccine and bacterial products within specific regions, such as the US.
- Provide strategic oversight and leadership to a multidisciplinary team of regulatory professionals, ensuring alignment with company objectives and regional regulatory requirements.
- Drive the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications, Biologics License Applications (BLAs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs), to regulatory authorities.
- Collaborate with cross-functional teams, including R&D, clinical development, manufacturing, and commercial functions, to ensure regulatory compliance and alignment of regulatory activities with product development milestones.
- Foster relationships with regional regulatory authorities, including the FDA, to facilitate communication, negotiations, and interactions related to regulatory submissions and approvals.
- Monitor regulatory developments, changes, and trends within specific regions, assessing their impact on product development and commercialization strategies, and provide strategic guidance to executive leadership.
- Manage regulatory risks and opportunities, proactively identifying potential obstacles to regulatory approval or compliance and developing mitigation strategies to address them.
- Provide regulatory guidance and support for post-marketing activities, including variations, renewals, labeling updates, and compliance initiatives, to maintain product registrations and ensure ongoing regulatory compliance.
- Represent the company's interests in industry forums, working groups, and regulatory meetings, advocating for regulatory policies and positions that support product development and commercialization objectives.
- Serve as a subject matter expert on regional regulatory requirements, guidelines, and best practices, providing training, mentorship, and guidance to regulatory team members and cross-functional stakeholders.
- Collaborate with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.
- Prepare and present regulatory updates, progress reports, and strategic recommendations to senior and/or executive leadership and regulatory governance committees, informing decision-making and driving regulatory excellence within the organization.
- Other duties as assigned.
Minimum Job Requirements
Qualifications
- Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
- 12+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on vaccine and/or bacterial products required.
- Proven track record of successful leadership and management of teams, with demonstrated ability to develop and execute regulatory strategies, drive regulatory submissions, and achieve regulatory approvals.
- Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines, with experience in interacting with regulatory authorities.
- Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across functions and regions.
- Strategic mindset with the ability to anticipate challenges, identify opportunities, and develop innovative solutions to achieve regulatory objectives.
Competencies
- Ability to develop and execute regulatory strategies tailored to specific regions, taking into account regional regulatory requirements, guidelines, and best practices.
- Strong leadership skills with the ability to effectively lead and motivate a multidisciplinary team, foster collaboration, and drive results in a fast-paced and dynamic environment.
- Proficiency in preparing and submitting regulatory documents, including INDs, BLAs, NDAs, and MAAs, to regulatory authorities, with a thorough understanding of regulatory submission requirements and processes.
- Keen awareness of regulatory developments, changes, and trends within specific regions, with the ability to analyze their impact on product development and commercialization strategies and provide strategic guidance to executive leadership.
- Strong interpersonal and communication skills with the ability to effectively engage and collaborate with internal stakeholders, cross-functional teams, and external regulatory authorities to achieve regulatory objectives.
- Ability to identify regulatory risks and opportunities, proactively assess their potential impact on regulatory approval or compliance and develop mitigation strategies to address them effectively.
- Experience in preparing teams for regulatory inspections, managing interactions with regulatory inspectors, and leading post-inspection activities to address inspection findings and ensure compliance with regulatory requirements.
Other Requirements
- This position has significant managerial and decision-making authority.
- Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month
Essential Physical Requirements
- Ability to articulate clearly and conduct verbal presentations with large and small audiences.
- Ability to travel via automobile and/or airplane.
- Ability to view video display terminal images < 18 away from face for extended period of time up to four (4) hours at a time.
- Ability to operate a computer keyboard and telephone.
- Ability to sit for extended periods of time up to four (4) hours at a time.
- Ability to lift, tug, pull up to fifteen (15) pounds.
To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.
DISCLAIMER
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.
You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.
EEO:Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
