GSK
Director, Regulatory Affairs, Specialty
GSK, Rockville, Maryland, us, 20849
Site Name:
USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - RockvillePosted Date:
Aug 28 2024
Job Purpose
Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. 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 labeling, commensurate with the available data.
Key Responsibilities
Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.
Ensure the regulatory strategy will deliver the needs of the local region(s), taking into account the needs of other regions globally
Implement the regional strategy(s) in support of the project globally
Lead regulatory interactions and the review processes in local region
Ensure appropriate interaction with regional commercial teams in local region
Ensure compliance with regional requirements at all stages of product life from C2MD
Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities
Capable of providing assessment of potential in license molecules
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree
Experience in Regulatory Affairs within a pharmaceutical organization
Experience working with Global Health Authorities and submissions for Pharmaceutical products
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
PhD or Masters’ degree in life sciences or pharmacy
Strong technical knowledge required to be able to assess regulatory compliance of products
Ability to interact with regulatory officials and support advocacy initiatives
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USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - RockvillePosted Date:
Aug 28 2024
Job Purpose
Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. 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 labeling, commensurate with the available data.
Key Responsibilities
Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.
Ensure the regulatory strategy will deliver the needs of the local region(s), taking into account the needs of other regions globally
Implement the regional strategy(s) in support of the project globally
Lead regulatory interactions and the review processes in local region
Ensure appropriate interaction with regional commercial teams in local region
Ensure compliance with regional requirements at all stages of product life from C2MD
Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities
Capable of providing assessment of potential in license molecules
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree
Experience in Regulatory Affairs within a pharmaceutical organization
Experience working with Global Health Authorities and submissions for Pharmaceutical products
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
PhD or Masters’ degree in life sciences or pharmacy
Strong technical knowledge required to be able to assess regulatory compliance of products
Ability to interact with regulatory officials and support advocacy initiatives
#J-18808-Ljbffr