Regulatory Affairs, Senior Manager, Influenza, US Region
- BS with 6+ years of significant experience in regulatory affairs or appropriate relevant experience in scientific function in vaccine industry combined with at least 3 years direct RA experience.
- Requires scientific and regulatory knowledge in CMC, Clinical, OR Non-clinical but with an ability and willingness to work in all three disciplines.
- Operational knowledge of IND and/or BLA regulations and experience in US regulations pertinent to product development and post licensure life-cycle maintenance activities.
- Experience in liaison with major regulatory Agencies
- Demonstrated knowledge in regulatory affairs and drug/vaccine development or equivalent
- MS degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline plus 4 years of regulatory experience
- Pharmaceutical development or regulatory affairs experience with biologics preferred
- 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
- 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
- Enterprise thinking – Understand the constraints and drivers of other functions and the potential impact on regulatory affairs, including how regulatory affairs may facilitate in achieving the overall corporate goal
- 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 regulatory affairs aspects of a given project on technical/nonclinical/clinical or procedural aspects
- Participate in project/product-related discussions and provide strategic, scientific and regulatory affairs input, for all parts of regulatory affairs aspects of given project on technical or procedural aspects
- Provide input into the asset specific regulatory strategy on a global scale
- 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 GR
- For cross-product sections or stand-alone documents work with the functional regulatory groups to ensure content is aligned with targeted overall profile of the product
- Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for technical/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 technical/nonclinical and procedural and accountable for one or several of the regulatory affairs 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 Regulatory Process 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 regulatory affairs 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 regulatory affairs specific activities within technical/nonclinical or procedural) in line with the overall project plan and regulatory affairs milestones
You may apply for this position online by selecting the Apply now button.
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