Head of Regulatory Affairs for European Partnership Markets
4 weeks ago
Job Purpose:
We are seeking a highly experienced and skilled professional to lead our regulatory strategy and governance for the European Partnership Markets. This role will be responsible for developing and implementing regulatory strategies to support the Pharmaceutical business in the region, ensuring compliance with regulatory requirements and driving commercial growth.
Key Responsibilities:
- Lead regulatory strategy to underpin the Pharmaceutical business in the European Partnership Markets
- Leadership and coordination of regulatory affairs activities completed in operational matrix (Partnership Team, Global CD and 3rd party Partner)
- Third-party contract owner, and responsible for governance and oversight, including accountability for audit program and issue escalation
- Builds, maintains and leads an efficient and well-motivated team ensuring appropriate prioritisation and flexible resourcing including driving and measuring performance
- Leads the resource management, objective setting and review, development and coaching of staff
- European Partnership Markets Regulatory representation on key projects and strategic initiatives
- Ensure the development and optimisation of standardized, efficient and compliant processes across the European Partnership Markets
- Leads regulatory risk management for the European Partnership markets. Ensures responsibilities relating to regulatory conformance are adhered to. Regulatory Lead at audits and inspections. Leads issue management activities as appropriate
- Builds and maintains effective relationships with internal regulatory, quality, commercial, & supply chain groups
Requirements:
- At least 10 years of relevant industry experience in Regulatory Affairs of which a considerable part has been in leadership positions
- Experience of leading effectively at senior levels and in a matrix across functions
- Local operating company experience is required
- Degree or masters/ PhD in scientific discipline, additional education in leadership is beneficial
- Area of specialization: Life Sciences / Pharmacy / professions aligned to medicine
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeWe are seeking a highly skilled and experienced Regulatory Affairs professional to lead our efforts in the European Partnership Markets. As Head of Regulatory Affairs for European Partnership Markets, you will be responsible for developing and implementing regulatory strategies to support the growth and success of our business in this region.Key...
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