Global Regulatory Affairs Director
3 weeks ago
**Site Name**: USA - Maryland - Rockville, USA - District of Columbia - Washington Dc, USA - Maryland - Baltimore
**Posted Date**: Jun 11 2024
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.
**Job Purpose**:
Ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned asset(s), across all stages of the product development and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP). This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data.
**Key Responsibilities**:
Accountable to the asset GRL and/or the Global Regulatory TG Head for development and delivery of appropriate regulatory strategy(ies) according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to VP level and representing GSK GRA in interactions with key regulatory agencies (EMA, CBER, PMDA etc). Work closely with R&D, Medical and Commercial teams to secure best possible labelling commensurate with the available data:
- Ensuring and driving the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally.
- Provide strategic regulatory input for all development stages of the project/product within a given product portfolio to key stakeholders.
- Liaise closely with other GRA teams such as non-clinical, CMC, Labelling and AdPromo through the Regulatory Matrix Team (RMT).
- Lead regulatory interactions and the review processes in local region e.g. be the point of contact to CBER for the assigned asset(s).
- Ensuring appropriate interaction with regional commercial teams in local region.
- Ensuring compliance with regional requirements at all stages of product life from early development to life cycle activities
- Proven capability to advocate scientifically sound approaches persuasively to senior leaders in GSK and at Health Authorities
- Capable of providing assessment of potential in license vaccines
**Basic Qualifications**:
- Bachelor’s degree in biological or healthcare science
- Five or more years of experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence.
- Three or more years of experience of leading regional development, submission and approval activities in local region(s).
**Preferred Qualifications**:
- MS or PhD. In biological or healthcare science
- Capable of organising and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority
- Extensive knowledge of clinical trial and licensing requirements in region and ideally sound knowledge globally.
- Extensive knowledge of relevant area of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area.
- Ideally also a significant external network at least into other pharmaceutical companies and recognised internally and externally as an expert broadly or in specific areas of regulatory affairs
- Able to deputise for GRL for assigned assets
- A solid experience in procedural/ registration US regulatory affairs (including as US authorised agent - liaison with US FDA)
- Knowledge in IND and BLA regulations and US regulations pertinent to product development and licensure/ post licensure
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
**Why GSK?**
**Uniting science, technology and talent to get ahead of disease together.**
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people.
-
Director Regulatory Affairs
4 days ago
Rockville, United States Scientific Search Full timeDirector of Regulatory Affairs Location: Rockville, MD or Remote Summary Join my client, a pioneering biotech firm revolutionizing hemostasis management. As the Director of Regulatory Affairs, you'll lead the charge in ensuring regulatory compliance and driving strategic initiatives for groundbreaking platelet-based products that save lives. Why You Should...
-
Director, Global Regulatory Affairs, Vaccines
2 weeks ago
Rockville, Maryland, United States GlaxoSmithKline Full timeSite Name: USA - Maryland - Rockville, USA - Pennsylvania - Upper ProvidencePosted Date: Apr Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity...
-
Director, Global Regulatory Policy
4 weeks ago
Rockville, Maryland, United States Merck Full timeJob DescriptionThe Global Regulatory Policy & Intelligence (GRPI) team advocates for regulatory policy that supports our company's business goals, developing wider support for our causes and maintaining a strong reputation as a science-led biopharmaceutical leader. We work in partnership with the company's Research Laboratories divisions and most directly...
-
Rockville, United States Medix™ Full timeKey Responsibilities:Collaborate with cross-functional teams to develop and implement regulatory strategies, manage regulatory risks, and ensure compliance with current regulations for cell therapy products.Prepare and manage regulatory submissions (INDs, CTAs, BLAs/MAAs) to agencies like the FDA and EMA.Ensure quality and accuracy of regulatory submissions,...
-
Senior Manager, Global Regulatory Affairs
2 weeks ago
Rockville, Maryland, United States GlaxoSmithKline Full timeSite Name:USA - Maryland - RockvillePosted Date:Jun 5 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...
-
Senior Manager, Global Regulatory Affairs
4 weeks ago
Rockville, Maryland, United States GlaxoSmithKline Full timeSite Name: USA - Maryland - RockvillePosted Date: Jun 5 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...
-
Rockville, United States GlaxoSmithKline Full timeSite Name: Siena, GSK House, Italy - Siena, Switzerland - Zug, USA - Maryland - RockvillePosted Date: May 31 2024The Regulatory Affairs Vaccines Therapeutic Group is looking for a new team member to join and work on one of our accelerator projects.The purpose of this team is to ensure the development of appropriate global and/or regional regulatory...
-
Rockville, Maryland, United States GlaxoSmithKline Full timeSite Name: Siena, GSK House, Italy - Siena, Switzerland - Zug, USA - Maryland - RockvillePosted Date: May The Regulatory Affairs Vaccines Therapeutic Group is looking for a new team member to join and work on one of our accelerator projects.The purpose of this team is to ensure the development of appropriate global and/or regional regulatory strategy(s) and...
-
Rockville, United States ZettaJoule, Inc. Full timeJob Title: Vice President, Business Development and Regulatory AffairsLocation: Rockville, Maryland, USAReports To: President and CEOCompany Overview: ZettaJoule is a pioneering nuclear fission technology integrator and project developer dedicated to revolutionizing the energy supply with clean, sustainable solutions. Our mission is to drive innovation and...
-
Director, Global Logistics
2 weeks ago
Rockville, United States Meso Scale Discovery Full timeThe 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...
-
Director, Global Logistics
2 weeks ago
Rockville, United States Meso Scale Discovery Full timeThe 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...
-
Director, Global Logistics
3 weeks ago
Rockville, United States MESO SCALE DIAGNOSTICS, LLC. Full timeThe 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...
-
Rockville, Maryland, United States United States Pharmacopeia Full timeDescriptionWho 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 Passion for...
-
Rockville, United States United States Pharmacopeia Full timeDescription 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...
-
Public Affairs Officer
4 weeks ago
Rockville, Maryland, United States USAJobs Full timeDutiesThe successful candidate will perform the full range of public affairs duties.Such duties include but are not limited to:Assist in the administration of stakeholder outreach that contributes to the public understanding of NRC programs and policies related primarily to headquarters and national activities and issues. Coordinates closely with Office...
-
Public Affairs Officer
4 weeks ago
Rockville, Maryland, United States Non-Departmental Agency Full timeSummary These positions are located in Office of Public Affairs in Rockville, Maryland, Headquarters and in Arlington, Texas, Region IV.The supervisor is Holly Harrington, Acting Office Director. This position is Bargaining Unit with the National Treasury Employees Union, Chapter 208 This position IS not subject to Confidential Financial Disclosure...
-
VP, Business Development and Gov't Affairs
1 week ago
Rockville, United States ZettaJoule, Inc. Full timeJob Title: Vice President, Business Development and Regulatory AffairsLocation: Rockville, Maryland, USAReports To: PresidentCompany Overview: ZettaJoule is a pioneering nuclear fission technology integrator and project developer dedicated to revolutionizing the energy supply with clean, sustainable solutions. Our mission is to drive innovation and create...
-
VP, Business Development and Gov't Affairs
1 week ago
Rockville, United States ZettaJoule, Inc. Full timeJob Title: Vice President, Business Development and Regulatory AffairsLocation: Rockville, Maryland, USAReports To: PresidentCompany Overview: ZettaJoule is a pioneering nuclear fission technology integrator and project developer dedicated to revolutionizing the energy supply with clean, sustainable solutions. Our mission is to drive innovation and create...
-
Vice President, Regulatory and Licensing
4 weeks ago
Rockville, United States X-Energy Full timeAbout X-energy X-Energy is a Gen IV nuclear power plant and fuel design company working towards completion of the design, licensing, and construction of its compellingly safe and revolutionary reactor design. We are staffing up with the world's most ambitious and devoted talent who share our vision of providing carbon-free, safe energy. This is a great...
-
Rockville, United States Links Global Full timeJob DescriptionJob DescriptionInternship AnnouncementUnpaid InternshipStart date: 09/07/2022Duration: 14 weeksLocation: Rockville, Maryland, near Rockville Metro Station, Red LineThe Links Global Digital Marketing Internship Program is for undergraduates studying one or more of the following areas of education: digital marketing communication, writing,...
