We are looking for an ambitious Manager/Associate Director of Regulatory Affairs to ensure the development of appropriate global and/or regional regulatory life-cycle strategy(s) and their execution for assigned products to meet the needs of the business. This goal has to be achieved whilst ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible life cycle management and expansion commensurate with the available data, and through optimum life cycle maintenance support.

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Accountable to Senior Director of Respiratory Established Products and VP, Global Regulatory Established Products for development of appropriate global and/or regional regulatory life cycle strategy(s) (expansion, management, and maintenance) and for delivery according to plans. 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 with the GRL and/or Medicine Development Team/Medicine Commercial Team (MDT/MCT), to ensure a robust regulatory strategy is in place to support the regulatory life-cycle strategy and meet the needs of the key markets. Work closely with local / regional commercial team in prioritized countries to deliver the best possible life-cycle management commensurate with available data and in line with the GDS. Lead interactions with local / regional regulatory authorities.

In this role you will

• Proactively develop regulatory life-cycle strategy (expansion, management, and maintenance) that will deliver the needs of the local region(s), taking in to account the needs of other regions globally.
• Implement the regional strategy(s) in support of the global regulatory life-cycle strategy.
• Lead regulatory interactions and the review processes in local region.
• Ensure effective partnerships with stakeholders and senior leaders across GRA, safety, global medical and commercial teams and local regulatory counterparts in key markets.
• Ensure compliance with global/ regional requirements and delivery of unfulfilled regulatory commitments.
• Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for a product

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• BSc in Biological or Healthcare Science or equivalent
• Experience of life-cycle management including clinical line extensions of the drug development process in regulatory affairs preferred.
• Experience leading regional life-cycle expansion strategies and delivering submission and approval activities in local region(s)
• Experience with clinical trial and life-cycle management licensing requirements in key markets in the region and ideally knowledge of other key Agency processes globally.
• Experience in relevant therapy area, and ability to further develop necessary specialist knowledge for the product or therapy area.
• Facilitates dialogue between team and matrix members to contribute their ideas. Capable of developing and recommending strategies for change and foster strong matrix working.

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:

• PhD in Biological or Healthcare Science or equivalent.
• Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion
• Constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving process.
• Ideally good listening and comprehension skills; proactive in identifying potential issues and escalating them accordingly.
• Good overall business acumen. Understands the needs of and interdependencies with, other functions. Understands the competitive landscape in the commercial space to support life-cycle strategies.
• Capable of identifying product or team issues in advance and seeking necessary help and support to resolve.
• Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognises potential long-term issues for products.

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