At a Glance
- Tasks: Lead regional regulatory strategy and ensure compliance with global standards.
- Company: Join GSK, a leader in healthcare innovation and equality.
- Benefits: Competitive salary, hybrid work, bonuses, and comprehensive health benefits.
- Other info: Dynamic role with opportunities for mentorship and cross-functional collaboration.
- Why this job: Make a real impact in global healthcare while advancing your career.
- Qualifications: Bachelor's degree in life sciences and proven regulatory experience required.
The predicted salary is between 86250 - 143750 € per year.
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 is 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 close collaboration and alignment with respective Global Regulatory Lead (GRL), Local Operating Company Regulatory Affairs (LOC RA) and Regional Medical & Commercial Leads.
Key Responsibilities
- Provide deep regulatory knowledge and international markets expertise to anticipate opportunities and risks, ensuring seamless regional integration into global regulatory strategy.
- 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.
- Proactively develop and implement regional regulatory strategy aligned with enterprise goals and local opportunities, in compliance with local requirements and GSK policies.
- Represent Regulatory function in collaboration with regional stakeholders, fostering timely alignment with the regional team on strategies and priorities and emerging business opportunities prior to and during enterprise formal governances.
- 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.
- 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.
- Contribute to the development of Global Regulatory Strategy (GRS) ensuring alignment with core product labeling and regional regulatory requirements.
- 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.
- Collaborate with GRL and LOC RA at early stages of development, providing expertise and guidance on specific local regulatory requirements and their implementation in the global strategy.
- Attain regulatory breakthroughs, evaluating likelihood of regulatory success and developing risk mitigation measures.
- Lead the Regional Strategy in interactions between GRL and LOC RA to ensure timely regulatory input, support operational and compliance activities, ensure right dossier generation, timely execution of submission plans, and responsive communication.
- Seek processes optimization opportunities, sharing learnings and best practices across the teams.
- Proceed with appropriate handovers to relevant areas after regulatory approval milestones are reached to ensure flawless execution of planned strategy and launch readiness.
- 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.
- Anticipate and escalate risks and issues related to regulatory strategy and supply disruption in the region.
- Lead and implement regional innovation initiatives aligned to GRA objectives.
- Support continuous improvement for regulatory plans and act in mentorship of team members as required.
Qualifications
Basic Qualification
- Bachelor Degree in a scientific discipline such as life sciences, pharmacy, medicine, or equivalent.
- Proven experience of leading regional development, submission and approval activities in region(s) and/or globally, with a track record of successful relationships with one or more Health Authority.
- Extensive experience of all phases of the drug development process in regulatory affairs.
- Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally.
- Extensive knowledge of relevant areas of medicine, or proven track record of developing product/therapeutic knowledge in new area.
Preferred Qualification
- Advanced degree (Masters, PharmD, MD, or PhD) in a relevant scientific discipline.
- Direct experience in developmental regulatory strategy.
- Background in local operating company regulatory operations or labeling.
- Experience contributing to regulatory policy, advocacy, or interacting with regional health authorities.
- Track record of leading cross-functional process improvements or portfolio prioritisation initiatives.
- Experience coaching and developing multi-cultural teams.
Location & Benefits
Location: London, Siena, Wavre (Belgium), or Poznan. This role is hybrid with regular on-site collaboration – typically two to three days on site per week.
Salary Range (Poland): PLN 410,250 – PLN 683,750 gross annually. Italian Salary Range: EUR 86,250 – EUR 143,750. Belgium Salary Range: EUR 111,750 – EUR 186,250.
Benefits include an annual bonus (if applicable), share-based long-term incentive program, private healthcare, additional paid days off, life insurance, private pension plan, fully paid parental leave and care of family member leave.
Equal Opportunity Employer
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, military service or any basis prohibited under federal, state or local law.
Regional Regulatory Affairs Director (International) employer: WISE Campaign
GSK is an exceptional employer that fosters a collaborative and innovative work culture, particularly for the Regional Regulatory Affairs Director role. With a strong commitment to employee growth, GSK offers extensive benefits including private healthcare, generous parental leave, and opportunities for professional development, all within vibrant locations like London and Poznan. The hybrid work model promotes a healthy work-life balance while ensuring employees are engaged in meaningful projects that contribute to global health advancements.
StudySmarter Expert Advice🤫
We think this is how you could land Regional Regulatory Affairs Director (International)
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend events, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory strategies. Understand their products and how they align with regional requirements. This will help you showcase your expertise and fit for the role.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the job description. Highlight your successes in regulatory affairs and how you've navigated complex environments to achieve results.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regional Regulatory Affairs Director (International)
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in regulatory affairs, especially in international markets. We want to see how your background aligns with the role of Regional Regulatory Affairs Director.
Showcase Your Expertise:Don’t hold back on sharing your deep regulatory knowledge and any successful relationships you've built with health authorities. We’re looking for someone who can bring valuable insights to our team!
Be Clear and Concise:When writing your application, keep it straightforward and to the point. Use clear language to convey your achievements and how they relate to the responsibilities outlined in the job description.
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensure you’re considered for this exciting opportunity!
How to prepare for a job interview at WISE Campaign
✨Know Your Regulatory Stuff
Make sure you brush up on your regulatory knowledge, especially regarding international markets. Understand the specific requirements and challenges in the regions you'll be working with, as this will show your potential employer that you're not just familiar with the basics but can also anticipate opportunities and risks.
✨Align with Global Strategies
Familiarise yourself with the company's global regulatory strategies and how they align with regional goals. Be prepared to discuss how you can contribute to this alignment and what insights you can bring from your previous experiences that would benefit the overall strategy.
✨Showcase Your Leadership Skills
As a Regional Regulatory Affairs Director, you'll need to demonstrate strong leadership capabilities. Prepare examples of how you've successfully led teams or projects in the past, particularly in cross-functional settings. Highlight your experience in mentoring and developing multicultural teams, as this is crucial for the role.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills and ability to navigate complex regulatory environments. Think of specific instances where you've had to overcome regulatory hurdles or implement innovative solutions, and be ready to share these stories during the interview.
