Executive Director and Head Established Products Therapeutic Group

vor 4 Wochen

Zug, Schweiz GSK Vollzeit

**Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Rixensart, GSK HQ, USA - Massachusetts - Waltham, Zug House
**Posted Date**: Dec 11 2024
**Job Purpose**:
The Executive Director is accountable to the SVP, Regulatory Affairs Therapeutic Group, for influencing and driving the overall direction and strategy for the Established Products (EP) Therapeutic Group via the development and implementation of innovative regulatory strategies to optimize the life cycle management including divestment opportunities. The role will require extensive matrix working within GSK to SVP level and representing GSK with regulatory agencies as appropriate. This role will oversee the budget, staffing and operations.

The Executive Director has full accountability for overseeing regulatory support for the EP portfolio, including the associated communication strategy to all regulatory authorities. The Executive Director is directly accountable for regulatory filings (excluding CMC and labelling), interactions globally and works with those outside of GRA (e.g. LOC, commercial and manufacturing) to facilitate other international filings. The Executive Director ensures that sound regulatory practices are fully integrated into regulatory work, that all regulatory obligations are met and that all documents submitted to regulatory agencies are appropriately reviewed to ensure they are complete, scientifically and technically accurate, of high quality, regulatory compliant and presented in a manner that facilitates agency review. The incumbent works across the GRA matrix with the relevant functional areas to ensure connectivity and alignment of activities for labelling and CMC.

**Key Responsibilities**:

- Leads directly and indirectly all regulatory activity in support of assigned EP product portfolio, working across the regulatory matrix to ensure alignment with business strategies.
- Represents the global regulatory function as the business partner to the General Medicine commercial leadership team and General Medicine PALT ensuring regulatory insights are incorporated into business strategies, regulatory risks are managed and obligations met.
- Provides leadership to Portfolio Optimisation regulatory activities including market expansion and divestment/discontinuation in support of business goals including representation on senior boards including Portfolio Optimisation Board.
- Provides leadership of function assessing and responding to changing business unit strategy; define and build regulatory capabilities to support.
- Exhibits leadership in the formulation and execution of global regulatory strategies and assist in the development of and implementation of policies and strategies that optimize product stewardship.
- Monitors and anticipates regulatory, scientific and pertinent legal issues related to the regional portfolio and assess potential impact on the Company, to advise management on events of significance to the Company’s business interests; influences changes in guidelines and regulations to strengthen the regulatory review process and ensures core operations are proactively aligned with emerging policies.
- Acts as a credible, influential, respected spokesperson with external agencies and third parties, ensuring appropriate, proactive communication and assuring collaborative approaches to agency and third party interactions. Works with other stakeholders to proactively shape the external environment in a manner consistent with GSK principles and priorities.

**_ Why you?_**

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

- Bachelor’s degree
- 10+ years' experience in Regulatory Affairs
- Previous management line-management experience

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

- PhD
- Extensive knowledge of relevant therapeutic area or proven track record of being able to develop product / therapeutic knowledge in new area
- Proven experience of leading development, submission and approval activities including track record of organizing and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority
- Extensive knowledge of clinical trial, licensing, supply chain and life cycle management requirements in priority markets and sound knowledge globally. Ideally, proven experience of leading regulatory activities globally

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

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 d

  • Trust Director, Trust Company

    vor 4 Wochen

    Zug, Schweiz AP Executive Vollzeit

    New - Location: Zug - Salary: Market related per month - Job Type:Permanent Posted about 5 hours ago We have been exclusively retained by a boutique trust company to find a trust director for its Zug office. Our client is well known for its professionalism and long-term commitment to its clients. This interesting position will involve the management and...

  • Executive Medical Role for Rare Disease Biotech

    Vor 4 Tagen

    Zug, Zug, Schweiz Morgan Prestwich - Life Science & Healthcare Executive Search Vollzeit

    Key Responsibilities: As the Medical Director, Europe, you will be responsible for: Leading the medical strategy for the European market Developing and implementing medical plans in conjunction with the Head of Medical Affairs Europe Collaborating with cross-functional teams to ensure alignment and effective execution of medical strategies Providing expert...

  • Private Wealth Director, Fiduciary

    vor 3 Wochen

    Zug, Schweiz AP Executive Vollzeit

    New - Location: Zug - Salary: Negotiable per annum - Job Type:Permanent Posted about 6 hours ago AP Executive have been given an exclusive mandate to recruit a private wealth director for a well-established internationally privately-owned fiduciary business. This is an important key hire for our valued client in Zug. For its Zug office we are looking for a...

  • Director, International Product Portfolio Strategy

    vor 4 Wochen

    Zug, Schweiz Exact Sciences Corporation Vollzeit

    Position Overview The Director International Product Portfolio Strategy oversees a specific product portfolio strategy which contribute fundamentally to the international business growth and for shaping and implementing the new product portfolio strategy. The Director International Product Portfolio Strategy will be responsible for defining the strategy for...

  • Director International Product Portfolio Strategy

    vor 4 Wochen

    Zug, Schweiz Exact Sciences Corporation Vollzeit

    Position Overview The Director International Product Portfolio Strategy oversees a specific product portfolio strategy which contribute fundamentally to the international business growth and for shaping and implementing the new product portfolio strategy. The Director International Product Portfolio Strategy will be responsible for defining the strategy for...

  • Director, Inbound Product Marketing, Legal Tech

    vor 3 Wochen

    Zug, Schweiz Thomson Reuters Vollzeit

    **Director, Inbound Product Marketing, Legal Tech** Would you like to join an organization that is consistently recognized as a 'Top Employer to Work For’ across a broad range of categories, such as Culture, Work-Life Balance, Diversity & Inclusion, Opportunities for Women, Social Impact, Volunteerism? Are you curious about the legal industry, the...

  • Associate Director, HEOR

    vor 3 Wochen

    Zug, Schweiz Morgan Prestwich - Life Science & Healthcare Executive Search Vollzeit

    2 days ago Be among the first 25 applicantsDirect message the job poster from Morgan Prestwich - Life Science & Healthcare Executive SearchGlobal Head of Resourcing - Life Sciences RecruitmentJob Title: Associate Director, HEOR – Rare DiseaseLocation: Zug, Switzerland (Hybrid – 2 days per week in office)We are seeking an Associate Director, Health...

  • Associate Director, HEOR

    Vor 5 Tagen

    Zug, Schweiz Morgan Prestwich - Life Science & Healthcare Executive Search Vollzeit

    2 days ago Be among the first 25 applicants Direct message the job poster from Morgan Prestwich - Life Science & Healthcare Executive Search Global Head of Resourcing - Life Sciences Recruitment Job Title: Associate Director, HEOR – Rare Disease Location: Zug, Switzerland (Hybrid – 2 days per week in office) We are seeking an Associate Director, Health...

  • Medical Director

    vor 3 Wochen

    Zug, Schweiz Morgan Prestwich - Life Science & Healthcare Executive Search Vollzeit

    Our client is an innovative and advancing US HQ rare disease biotechnology company, specialising in pioneering developments focussed on Oncology and relative Neuro-Oncology conditions with high unmet need (Both adult and paediatric rare conditions).Following a recent breakthrough FDA approval for the treatment of adults in a relative rare Oncology condition,...

  • Pharmaceutical Sales Executive

    Vor 4 Tagen

    Zug, Zug, Schweiz Menarini Group Vollzeit

    Menarini Group is seeking a Pharmaceutical Sales Executive to join our team in Switzerland. As a key member of our commercial team, you will be responsible for driving the sales and support of our oncology products in the region.Key responsibilities include:Building relationships with key stakeholders, including local medical professionals and hospital...

  • Head of Marketing, Europe

    vor 3 Wochen

    Zug, Schweiz Morgan Prestwich - Life Science & Healthcare Executive Search Vollzeit

    Company OverviewOur client is an American biotechnology company specialising in oncology and rare diseases. As they expand their footprint in the European market, they are seeking a dynamic and experienced Head of Marketing, Europe to spearhead the commercial launch of their oncology product in the EU, starting with Germany.Position OverviewThe Head of...

  • Director, Global Medical Safety

    vor 3 Wochen

    Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

    Reporting to the VP, Global Medical Safety (GMS), the Director, Global Medical Safety will be responsible for working collaboratively to assess, track and document the ongoing benefit-risk profile of all products in development and marketing products. This includes contributing the safety sections of numerous aggregate reports (e.g., DSUR, PBRER, ASR),...

  • Director, Order to Cash Product Owner

    vor 4 Wochen

    Zug, Schweiz Johnson & Johnson Vollzeit

    **Director, OTC Product Owner**: **Description**: Johnson & Johnson Consumer Health Supply Chain is recruiting for a Director, OTC Product Owner located in Zug, Switzerland. Consumer Health is defining the future technology roadmap to support digital capabilities as the business spins off as a stand-alone company. As major programs evolve to deliver the...

  • Therapeutic Area Specialist

    Vor 4 Tagen

    Zug, Zug, Schweiz Johnson & Johnson Medical (Suzhou) Ltd. Vollzeit

    Job Summary:Johnson & Johnson Medical (Suzhou) Ltd. is seeking a talented Medical Science Liaison to join our team. As a key member of our Medical Affairs department, you will play a critical role in promoting the safe and effective use of our products among healthcare professionals.About the Position:The Medical Science Liaison is responsible for serving as...

  • Executive Assistant

    vor 3 Wochen

    Zug, Schweiz Huhtamaki Group Vollzeit

    Inspired to grow with your experience, learn and share with new colleagues? Huhtamaki is a key global provider of sustainable packaging solutions for consumers around the world, enabling wellbeing and convenience. Our innovative products protect on-the-go and on-the-shelf food and beverages, ensuring hygiene and safety, and help prevent food waste. - We are...

  • Head of Product Strategy

    vor 2 Stunden

    Zug, Zug, Schweiz DevITjobs Vollzeit

    Job Summary:We are seeking an experienced Head of Product Strategy to join our team at Dialectic, a pioneering crypto-native organization. In this role, you will be responsible for developing and executing a comprehensive product strategy that aligns with our company's vision and goals.You will work closely with cross-functional teams to identify business...

  • Therapeutic Area Manager Oncology, Switzerland

    vor 1 Woche

    Zug, Schweiz Menarini Group Vollzeit

    OverviewTherapeutic Area Manager Oncology, Switzerland - DeutschschweizReports to Country Manager Austria & SwitzerlandThe OpportunityThe TAM is responsible for the sale and support of Stemline products to both existing and potential customers. The goals of this position are to acquire new customer business, increase market share through acquiring new...

  • Head of Finance

    vor 4 Wochen

    Zug, Schweiz G-20 Group Vollzeit

    At G-20 Group, we are pioneering the integration of traditional financial strategies with the boundless potentials of cryptocurrency assets. We are seeking a dynamic** Head of Finance (100%) **with a rich background in treasury and cash flow management to help anchor and guide our financial strategies. This role commands not only the strategic development...

  • Director of Lifecycle Management

    Vor 6 Tagen

    Zug, Zug, Schweiz GlaxoSmithKline Vollzeit

    About the RoleWe are seeking a highly skilled Director of Lifecycle Management to join our team in Clinical Pharmacology. The successful candidate will be responsible for providing clinical pharmacology, therapeutic, and regulatory support for GSK's portfolio.The ideal candidate will have experience in the application of clinical pharmacology, modelling and...

  • Director of Product Growth

    vor 2 Wochen

    Zug, Schweiz EMEA Recruitment GmbH Vollzeit

    Lead the Growth of an Innovative Streaming Platform.EMEA Recruitment is searching for a dynamic Director of Product Growth to launch and scale a groundbreaking live multi-streaming platform.This role offers the chance to drive innovation, develop strategies, and lead the growth of a product that empowers creators and transforms how audiences engage with...