Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
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Position Summary
Lead the development of appropriate business-focused, high-quality, timely regional regulatory strategy and its execution for assigned asset(s), consistent with relevant enterprise goals and respective product profile. This goal has to be achieved as a component of an overall global regulatory approach while ensuring compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling in a close collaboration and alignment with respective Global Regulatory Lead (GRL), Local Operating Company Regulatory Affairs (LOC RA) and Regional Medical & Commercial Leads. The Regional Regulatory Lead masters the country requirements as well as acceleration opportunities to optimize the earliest approvals aligned with commercial plans working within a complex stakeholder matrix.
Key Responsibilities
Responsible for the development of optimal regional regulatory strategy and for its delivery according to plan. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level. The Regional RA Director is the regional single point of contact on assigned asset(s), accountable for liaison between GRLs, Medical, and Regional Commercial Leads, as well as the LOC RA in region with the goal to deliver best-in class regulatory strategy, achieve the cross-regional alignment and regional objectives.
1. Provide deep regulatory knowledge and international markets expertise, as well as knowledge of the therapeutic area, to anticipate opportunities and risks to ensure seamless regional integration into global regulatory strategy.
2. Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact on the regional regulatory strategy, converting regulatory updates into actionable insights.
3. Proactively develop and implement regional regulatory strategy aligned with enterprise goals and local opportunities, in compliance with local requirements and GSK policies.
4. Represent Regulatory function in collaboration with regional stakeholders, fostering timely alignment with the regional team on regional strategies and priorities and emerging business opportunities prior to and during enterprise formal governances.
5. Represent Regional Regulatory function in global forums and cross-functional collaboration to advocate regional business position and address region specificities, supporting resource planning at global level.
6. Serve as single point of contact for regional regulatory to GRLs in global initiatives and work with GRL to ensure alignment with V/MDT and PALT prior to R&D Governance.
7. Contribute to the development of Global Regulatory Strategy (GRS) ensuring alignment with core product labeling and regional regulatory requirements.
8. Drive early engagement with LOC RAs proactively sharing knowledge on clinical development programs and key project milestones, equipping local teams to partner in local launch readiness discussions.
9. Collaborate with GRL and LOC RA at early stages of development, leveraging expertise, providing insights and guidance on specific local regulatory requirements and their implementation in the global strategy for effective planning (e.g. clinical studies & GMPc requirements, pre-submission activities, and submission prioritization based on regulatory requirements and commercial opportunities).
10. Attain regulatory breakthroughs, evaluating the likelihood of regulatory success and developing risk mitigation measures.
11. Lead the Regional Strategy in interactions between GRL and LOC RA to:
- Ensure that LOC regulatory input for regulatory strategy planning is provided on a timely basis;
- Support operational and compliance activities for relevant assets, ensuring right dossier generation for the region and timely execution of regulatory submission plans, availability of regional marketing application dossier components [market specific requirements (MSRs), GMP documentation etc], briefing packages, timely responses to questions in collaboration with cross functional SMEs, GRLs and LOCs.
12. Seek processes optimization opportunities, sharing learnings and best practices across the teams.
13. Proceed with appropriate handovers to relevant areas after regulatory approval milestones are reached to ensure flawless execution of planned strategy and launch readiness.
14. Accountable for complete, accurate, and timely communication on the relevant assets’ key milestones, translating high-level program updates into actionable insights and strategic implications for the region.
15. Anticipate and escalate risks and issues related to regulatory strategy and supply disruption in region.
16. Lead and implement regional innovation initiatives, aligned to GRA objectives.
17. Support continuous improvement for regulatory plans and act in mentorship of team members as required.
Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
18. Bachelor Degree in a scientific discipline such as life sciences, pharmacy, medicine, or equivalent.
19. Proven experience of leading regional development, submission and approval activities in region(s) and/or globally. Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority
20. Extensive experience of all phases of the drug development process in regulatory affairs.
21. Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally.
22. Extensive knowledge of relevant areas of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area.
Preferred Qualification
If you have the following characteristics, it would be a plus:
23. Advanced degree (Masters, PharmD, MD, or PhD) in a relevant scientific discipline.
24. Direct experience in developmental regulatory strategy
25. Background in local operating company regulatory operations or labelling.
26. Experience contributing to regulatory policy, advocacy, or interacting with regional health authorities.
27. Track record of leading cross-functional process improvements or portfolio prioritisation initiatives.
28. Experience coaching and developing multi-cultural teams.
The annual base salary in Poland for new hires in this position ranges from PLN 410,250 to PLN 683,750 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. Italian Salary Range / Fascia retributiva in Italia: EUR 86,250 to EUR 143,750 Belgium Salary Range / Fourchette salariale – Belgique: EUR 111,750 to EUR 186,250 The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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.