Head of Regulatory Affairs for European Partnership Markets
2 months ago
We are seeking a highly experienced and skilled Regulatory Affairs professional to lead our regulatory strategy and operations for the European Partnership Markets. As a key member of our team, you will be responsible for developing and implementing regulatory strategies to support the growth and success of our business in this region.
Key Responsibilities- Develop and implement regulatory strategies to support the growth and success of our business in the European Partnership Markets.
- Lead regulatory affairs activities for product portfolio in the European Partnership Markets, including coordination of aligned Global Regulatory Content Delivery (CD) team activities and oversight of 3rd party partners and outsourced MAH responsibilities for non-EU countries.
- Further development and maintenance of standardized internal control framework in the European Partnership Markets.
- Line management, coaching and development of the team.
- Be an authority on the regulatory framework in the European Partnership Markets to provide guidance to the local business to ensure compliance and support commercial growth.
- Lead regulatory strategy to underpin the Pharmaceutical business in the European Partnership Markets to support competitive license approvals, market access, product launch and supply continuity.
- Leadership and coordination of regulatory affairs activities completed in operational matrix (Partnership Team, Global CD and 3rd party Partner), for product portfolio in the European Partnership Markets.
- 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.
- 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.
- Knowledge of regulatory specifics.
- Knowledge of the policies and regulatory climate in Europe.
- A proven track record of effective collaboration and negotiation with regulatory agencies.
- The ability to recognise, anticipate and discuss potential regulatory challenges with teams in the Business and Global Regulatory.
- High degree of comfort and positive engagement working as a member of a multifunctional team, in a leadership role or as a senior contributing member.
- Experienced in strategic interface with global functions and senior stakeholders.
- Strong management and project leadership skills, ability to provide advice and counsel to company staff in strategic decisions.
- Well-developed and demonstrable leadership skills.
- The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management.
- A competent and transparent communicator with excellent written, verbal and presentation skills.
- The ability to manage conflict in a consensus building manner showing sensitivity to building productive business relationships; demonstrates excellent ability to have conversations in which there may be varying and different opinions or approaches/options.
- Leading across the area to coach and mentor staff.
- Managing 3rd party vendors.
GlaxoSmithKline Services Unlimited 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).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and compliance efforts for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring that our products are compliant with all relevant regulatory...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and compliance efforts for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring that our products are compliant with all relevant regulatory...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and compliance efforts for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring that our products are compliant with all relevant regulatory...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and compliance efforts for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring that our products are compliant with all relevant regulatory...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and governance for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and providing guidance to our...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and governance for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and providing guidance to our...
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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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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and governance for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and governance for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob SummaryWe are seeking a highly experienced and skilled Regulatory Affairs professional to lead our efforts in the European Partnership Markets. As Head of Regulatory Affairs, you will be responsible for developing and implementing regulatory strategies to support the Pharmaceutical business in these markets.Key ResponsibilitiesLead regulatory strategy to...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob SummaryWe are seeking a highly experienced and skilled Regulatory Affairs professional to lead our efforts in the European Partnership Markets. As Head of Regulatory Affairs, you will be responsible for developing and implementing regulatory strategies to support the Pharmaceutical business in these markets.Key ResponsibilitiesLead regulatory strategy to...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob SummaryWe are seeking a highly experienced and skilled Head of Regulatory Affairs for European Partnership Markets to lead our regulatory strategy and governance in this region. The successful candidate will be responsible for developing and implementing regulatory strategies to support the growth and success of our business in Europe.Key...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and compliance efforts for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring that our products are compliant with all relevant regulatory...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and compliance efforts for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring that our products are compliant with all relevant regulatory...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and compliance efforts for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring that our products are compliant with all relevant regulatory...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and compliance efforts for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring that our products are compliant with all relevant regulatory...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs for European Partnership Markets to join our team at GSK. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of regulatory strategies to support the...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs for European Partnership Markets to join our team at GSK. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of regulatory strategies to support the...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and compliance efforts for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring that our products are compliant with all relevant regulatory...
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Brentford, Greater London, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeJob Title: Head of Regulatory Affairs for European Partnership MarketsWe are seeking an experienced and skilled Head of Regulatory Affairs to lead our regulatory strategy and compliance efforts for the European Partnership Markets. As a key member of our team, you will be responsible for ensuring that our products are compliant with all relevant regulatory...
