Associate Director, Global Regulatory Affairs

3 weeks ago

Rockville, United States GlaxoSmithKline Full time
Site Name: USA - Maryland - Rockville
Posted Date: Jun 27 2024

Job Purpose:

Ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s), across all stages of the product life cycle and consistent with Asset Development Strategy /Integrated Asset plan. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Asset Profile, commensurate with the available data.

Responsibilities:

  • Accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate (regional) regulatory strategy(s) and for delivery according to plans.
  • Planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP (Vice Presidents) level and representing GSK with at least the local regulatory agency.
  • Work within the larger GSK matrix organization (i.e., Early/Medicine/Vaccine development Team, Commercial, etc.) to ensure a robust Regulatory strategy is in place to support particular stage of product life cycle to secure product licensure in key markets identified in the Integrated Asset Plan as well as securing best possible labeling commensurate with the available data.
  • Lead interactions with local/regional regulatory authorities.
  • Proactively developing regulatory strategy, considering the needs of other regions globally.
  • Implementation of the regional strategy(s) in support of the project globally.
  • Lead regulatory interactions and the review processes for assigned asset strategy.
  • Ensuring appropriate interaction with global/regional counterparts and commercial teams where applicable.
  • Ensuring compliance with global/regional requirements at all stages of product life cycle.
  • Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the assigned asset and the impact this will have on the regulatory strategy.

Basic Qualifications:

  • Bachelor's Degree.
  • Experience of all phases of the drug development process in Regulatory Affairs preferred.
  • Knowledge of clinical trial and licensing requirements in all major countries (EU, US, JP, China) and ideally knowledge of other key Agency processes globally.
  • Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine.

Preferred Qualifications:

  • Capable of leading regulatory development, submission, and approval activities in assigned region(s).
  • Higher degree preferred in biological or healthcare science.
#J-18808-Ljbffr

  • Global Regulatory Affairs Director

    1 day ago

    Rockville, Maryland, United States GlaxoSmithKline Full time

    Job Overview: We are seeking an Associate Director, Global Regulatory Affairs to join our team at GlaxoSmithKline. **Job Summary:** As an Associate Director, Global Regulatory Affairs, you will be responsible for developing regulatory strategies for assigned assets and ensuring compliance with internal processes and regulatory requirements. **Key...

  • Global Regulatory Affairs Director

    3 weeks ago

    Rockville, Maryland, United States GlaxoSmithKline Full time

    Job SummaryWe are seeking a highly skilled and experienced Global Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for developing and executing global and/or regional regulatory strategies for assigned assets, across all stages of the product life cycle.Key...

  • Director, Global Regulatory Affairs, Vaccines

    2 weeks ago

    Rockville, Maryland, United States GlaxoSmithKline Full time

    Job SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Leader to join our team at GlaxoSmithKline. As a key member of our Global Regulatory Affairs team, you will be responsible for ensuring the development and execution of regulatory strategies for assigned vaccines, across all stages of the product life cycle.Key...

  • Associate Director, Global Regulatory Affairs

    3 weeks ago

    Rockville, United States GlaxoSmithKline Full time

    Site Name: USA - Maryland - RockvillePosted Date: Jun 27 2024Job Purpose:Ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s), across all stages of the product life cycle and consistent with Asset Development Strategy /Integrated Asset plan. This goal has to be achieved while ensuring...

  • Director, Global Regulatory Affairs

    3 weeks ago

    Rockville, Maryland, United States GlaxoSmithKline Full time

    About the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory strategies to...

  • Global Regulatory Affairs Director

    2 weeks ago

    Rockville, Maryland, United States GlaxoSmithKline Full time

    Job Summary:We are seeking a highly skilled Global Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for developing and executing the appropriate regulatory strategy for assigned assets, across all stages of the product development and consistent with the Vaccines...

  • Associate Director, Regulatory Affairs CMC

    2 weeks ago

    Rockville, Maryland, United States Arcellx, Inc. Full time

    Job DescriptionCompany OverviewArcellx, Inc. is a leading biotechnology company dedicated to developing innovative therapies for patients with severe diseases.Job SummaryWe are seeking an experienced Associate Director, Regulatory Affairs CMC to join our team. The successful candidate will be responsible for leading the development and implementation of...

  • Regulatory Affairs Director

    2 weeks ago

    Rockville, Maryland, United States GlaxoSmithKline Full time

    Job Purpose:As a key member of the GlaxoSmithKline team, the successful candidate will be responsible for developing and executing global and/or regional regulatory strategies for assigned assets, across all stages of the product life cycle. This will involve ensuring compliance with both internal GSK processes and policies, as well as relevant regulatory...

  • Associate Director, Oncology Regulatory Strategy

    2 weeks ago

    Rockville, Maryland, United States GlaxoSmithKline Full time

    Job SummaryWe are seeking an experienced Associate Director to lead our Oncology Regulatory Strategy team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regional regulatory strategies to support the development and launch of our oncology products.Key ResponsibilitiesDevelop and...

  • Associate Director, Regulatory Affairs CMC

    3 weeks ago

    Rockville, United States Arcellx Full time

    Who We AreArcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are...

  • Director, Global Logistics

    3 months ago

    Rockville, United States MESO SCALE DIAGNOSTICS, LLC. Full time

    The Director of Global Logistics is responsible for the fulfillment planning function and shipment network design and optimization strategy, establishing a strong supply plan handoff to external partners and end-users. This role will be accountable for the implementation of end-to-end shipping operations planning world-wide, with particular focus on North...

  • Associate General Counsel, Regulatory

    3 weeks ago

    Rockville, United States Financial Industry Regulatory Authority , Inc. Full time

    This position is responsible for directing and managing the complete life cycle of the adoption of new regulatory requirements. The incumbent provides expert knowledge to the Board of Governors and senior management, advising them on high-impact, leg Regulatory, General Counsel, Associate, Legal, Business Services, Industry, Proposal

  • Medical Affairs Director

    2 weeks ago

    Rockville, Maryland, United States Aurinia Pharmaceuticals Full time

    {"OverviewAurinia Pharmaceuticals is seeking a seasoned Medical Affairs professional to lead the development and execution of strategic plans for the company's commercialized products and pipeline assets. The ideal candidate will have a strong background in nephrology or rheumatology and a proven track record of success in Medical Affairs leadership...

  • Regulatory Affairs Specialist

    3 weeks ago

    Rockville, Maryland, United States Food and Drug Administration Full time

    Job SummaryThis position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Regulatory Management Operations (ORMO). The incumbent provides strategic guidance and support to the Associate Commissioner for Regulatory Affairs (ACRA), Deputy ACRA and other Office of...

  • Senior Manager, Public Policy, International Government and Regulatory Affairs

    3 months ago

    Rockville, United States United States Pharmacopeia Full time

    Description Who is USP? The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of...

  • International Affairs Digital Marketing Internship

    2 days ago

    Rockville, Maryland, United States Links Global Full time

    Job OpportunityWe are seeking highly motivated and detail-oriented individuals to join our team as Digital Marketing Interns in International Affairs. As an intern, you will have the opportunity to gain hands-on experience in digital marketing, develop your skills in a dynamic and fast-paced environment, and contribute to the success of our organization.Key...

  • Global Logistics Director

    1 hour ago

    Rockville, Maryland, United States MESO SCALE DIAGNOSTICS, LLC. Full time

    Job Title: Director of Global LogisticsThe Director of Global Logistics is a key leadership position responsible for the strategic planning and execution of global logistics operations. This role will oversee the development and implementation of supply chain strategies to ensure efficient and effective transportation of goods worldwide.Key...

  • Senior Director, Product Management

    3 weeks ago

    Rockville, United States Immunocore Full time

    Job Details: Senior Director, Product Management (Global Medicines Leader)Full details of the job.Vacancy Name: Vacancy NoVacancy No: VN487Employment Type: Full TimeLocation of role:Key Responsibilities:MAIN PURPOSE OF JOB:Responsible for delivering on the long-term global strategy for KIMMTRAK (CEO of the molecule). KIMMTRAK is the first TCR, and the first...

  • Senior Director, Product Management

    3 weeks ago

    Rockville, United States Immunocore Full time

    Job Details: Senior Director, Product Management (Global Medicines Leader)Full details of the job.Vacancy Name: Vacancy NoVacancy No: VN487Employment Type: Full TimeLocation of role:Key Responsibilities:MAIN PURPOSE OF JOB:Responsible for delivering on the long-term global strategy for KIMMTRAK (CEO of the molecule). KIMMTRAK is the first TCR, and the first...

  • Senior Director, Global Capital Projects

    3 weeks ago

    Rockville, Maryland, United States GlaxoSmithKline Full time

    About the RoleWe are seeking a highly experienced and skilled Senior Director to lead our Global Capital Projects team. As a key member of our Engineering Leadership team, you will be responsible for the safe, efficient, and timely execution of major capital projects across our global supply chain.Key ResponsibilitiesDevelop and implement a comprehensive...