Director, Clinical Post-Approval, US Region, Regulatory Affairs
- Bachelors degree in chemistry, biology, biochemistry, pharmacy, or similarly applicable discipline.
- 10+ years significant experience in regulatory affairs, or appropriate relevant experience in scientific function in vaccine industry combined with at least 4 years direct RA experience ((or advanced degree and 10+ years experience).
- Requires scientific and regulatory knowledge pertinent to product development aspects, including direct experience in Clinical regulatory affairs/strategy and the development of clinical endpoints for biologics or vaccines.
- Operational knowledge of IND and NDA/BLA regulations and experience in US regulations pertinent to product development,
- Direct experience as liaison with US FDA
- Prior experience with biologics or vaccines is required.
PhD in Pharmacy, Chemistry, Biology, Medicine, or similar discipline.
Experience at a large pharmaceutical/vaccines company
- Strategic Leadership – Experience in providing strategic advice on integrated regulatory development plans and life cycle management, preferably for the US. Providing US-focused input into regulatory strategy, evaluating potential impact on overall project/product strategy. Leveraging internal and external regulatory and scientific networks to problem solve. Providing input into corporate regulatory positioning including US key considerations early in the product development. Writing/critically reviewing, while ensuring rigorous scientific content/quality/compliance, key documents targeting internal or external key audiences, including but not limited to annual reports, status reports on post marketing requirements/commitments related to clinical safety, clinical efficacy, or clinical pharmacology, briefing documents, key meeting summaries, and BLA modules.
- People & Program Management – Identifying and escalating regulatory or programmatic issues while proposing mitigations strategies and solutions/problem solving. Developing plans and timelines for complex projects and collaborating with other departments and teams in the delivery of outputs in a timely manner. Forming collaborative relationships and having high impact and influence on multicultural, diverse, and/or international teams. Ensuring that a corporate or departmental regulatory voice is clearly articulated and heard consistently and concisely in various cross functional teams.
- Enterprise thinking – Understand the constraints and drivers of other functions and the potential impact on regulatory affairs World-wide, including how regulatory affairs may facilitate in achieving the overall corporate goal.
- Proactive leadership – Identify issues and maximize opportunities. Quickly assimilate facts and data and develop an understanding of complex matters with the ability to translate this understanding as part of developing, mentoring, and coaching junior staff.
GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical companies with a broad range of innovative products in three primary areas: Pharmaceuticals, Vaccines and Consumer Healthcare. GSK vaccines are included in immunization campaigns in 182 countries with 860 million vaccine doses distributed to 170 countries in 2013, of which 80% were to developing countries. Our Vaccines R&D work focuses on discovering and developing vaccines to help protect people against a broad range of diseases and conditions across all age groups. We have a pipeline of 14 candidate vaccines in early, mid and late stage development against a range of diseases.
North America Regulatory Affairs (NARA) is a dynamic and growing part of GSK Vaccines' Global Regulatory Affairs Organization. The Rockville, MD-based group of regulatory experts focuses on GSK's U.S.-licensed and developing-vaccine pipeline and provides advice on U.S. regulatory strategy for cutting-edge, novel vaccine technology while also delivering on post-marketing reporting requirements, regulatory filings in support of new applications, and liaising with the U.S. FDA and global product leads. The group's leadership team members have diverse scientific backgrounds in virology, pharmacology, biochemistry, chemistry, and molecular biology, with decades of combined experience in drug development and vaccines.
As a Director, Post-Approval within North America Regulatory Affairs, you will be responsible for regulatory submissions, interactions, and strategy related to established/licensed US vaccines, primarily in the clinical discipline. The role interfaces proactively and seamlessly with the Global Regulatory Lead for the assigned products to provide US-focused strategic advice and execution of deliverables for US submissions and FDA interactions. The function has reporting requirements to the Group Lead within NARA and includes project and product management benchmarked to key performance indicators aligned with the department and global objectives.
The key responsibilities for this role include:
- Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.
- Interact with (or represents his/her area/product at) internal project related teams, for all parts of RA aspects of a given project on nonclinical, clinical or procedural aspects.
- Participate in project/product-related discussions and provide strategic, scientific and RA input, for all parts of RA aspects of given project on technical or procedural aspects.
- Provide input into the asset specific regulatory strategy on a global scale.
- Provide input into advertising and promotional review from a regulatory perspective.
- Provide support to the GRL via authoring, input and/or critical review of one or more specific sections (technical/nonclinical and/or procedural) of regulatory documents, Global Regulatory Plan(s) and/or Key Message Summaries.
- Coordinate (for one or more specific (technical/nonclinical and/or procedural) sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
- Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/nonclinical and/or procedural) and ensure that those documents meet regulatory requirements.
- Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/nonclinical and procedural aspects. Accountable for one or several of the RA aspects.
- Act as the point of contact for Regulatory Agencies for asset(s); Plan and lead activities associated with FDA meetings pertaining to a project/product
- Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s).
- Assess the regulatory impact of Changes pertaining to approved commercial products
- Be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
- Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
- Ensure planning and proper organization of activities (for one or more of RA specific activities within technical/nonclinical or procedural) in line with the overall project plan and RA milestones.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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