Senior Mgr or Director, Clinical, Global Regulatory Affairs
Rockville , Maryland
April 09, 2017
Basic qualifications:
6+ years significant experience in regulatory affairs, or appropriate relevant experience.
• Requires scientific and regulatory knowledge pertinent to development aspects, particularly Clinical RA and strategy
• Operational knowledge of IND and BLA regulations and experience in US regulations pertinent to product development, preferably vaccines/biological
• Experience in liaison with major regulatory Agencies, preferably FDA
• Demonstrated knowledge in regulatory affairs and drug/vaccine development or equivalent

Preferred qualifications:
Ph.D; Pharmacy, Chemistry, Biology or Medicine
Pharmaceutical development with biologics experience preferred.
• Experience in providing strategic advice on integrated regulatory development plans, and problem solving in cross-functional teams in drug/vaccine development
•Ability to coordinate and execute regulatory strategy for a given project/product.
•Ability to assess and determine regulatory strategy for development and life cycle management programs.
•Strategic thinker - ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy.
•Ability to identify and escalate issues to the Global Regulatory Lead and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
•Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams.
•Support the Global Regulatory Lead to ensure regulatory input is provided to other groups within GSK or to regulatory agencies, as appropriate.
•Proven influencing skills.
•Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
•Ability to resolve problems through resourceful use of information and contacts.
•Enterprise thinking - needs to assess the potential impact on RA, including how RA may facilitate in achieving the overall goal.
•Quality mindset
•Fluent in English, with excellent writing skills.
•Able to input into the Company's regulatory positioning, and write /critically review key documents targeting internal or external key audiences.
•In collaboration with the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.

•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 clinical RA strategy 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 clinical 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 of regulatory documents, Global Regulatory Plan(s) and/or Key Message Summaries.
• Coordinate (for one or more specific sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
• 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 and ensure that those documents meet regulatory requirements.
• Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical and procedural and accountable for one or several of the RA aspects.
• Act as the point of contact for Regulatory Agencies for assets ; 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).
• 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 clinical or procedural) in line with the overall project plan and RA milestones.


Contact information:

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