About the Company
GlaxoSmithKline (GSK) is a global healthcare company with a special purpose: to help people do more, feel better, live longer. We research, develop and manufacture innovative medicines, vaccines and consumer healthcare products. Our global presence and commitment to scientific innovation drive our mission to improve health worldwide. Join us and be part of a team dedicated to making a real difference.
Job Description
We are seeking an experienced and highly motivated Regulatory Affairs Manager to join our dynamic team in Guildford. In this pivotal role, you will be responsible for leading and executing regulatory strategies for our diverse portfolio of pharmaceutical products. You will ensure compliance with global and local regulations, manage product lifecycle activities, and serve as a key point of contact with regulatory authorities. This role demands a proactive individual with strong leadership skills and a deep understanding of the regulatory landscape.
Key Responsibilities
- Develop and implement robust regulatory strategies for assigned products and projects.
- Manage the preparation, submission, and maintenance of regulatory dossiers (e.g., MAAs, variations, renewals) to global health authorities.
- Serve as the primary liaison with regulatory agencies, leading interactions and negotiations.
- Provide expert regulatory guidance and support to cross-functional teams, including R&D, commercial, and manufacturing.
- Monitor and interpret new and evolving regulatory guidelines and assess their impact on product portfolio.
- Ensure timely approval of new products and maintenance of existing product licenses.
- Lead and mentor junior regulatory affairs professionals, fostering a culture of excellence and continuous improvement.
- Participate in due diligence activities for potential acquisitions or partnerships from a regulatory perspective.
Required Skills
- Bachelor's degree in a life science, pharmacy, or related field.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
- Demonstrable experience with major health authority submissions (e.g., MHRA, EMA, FDA).
- Thorough understanding of regulatory requirements for product development, registration, and post-market maintenance.
- Proven ability to manage multiple projects and deadlines in a fast-paced environment.
- Excellent written and verbal communication skills, with strong attention to detail.
- Proficiency in regulatory information systems and Microsoft Office Suite.
Preferred Qualifications
- Master's degree or PhD in a relevant scientific discipline.
- RAC (Regulatory Affairs Certification) credential.
- Experience with biologics or complex therapeutic areas.
- Prior experience leading regulatory teams or projects.
Perks & Benefits
- Competitive annual salary and performance-based bonuses.
- Comprehensive private healthcare package.
- Generous pension contribution scheme.
- 25 days annual leave plus bank holidays, with option to purchase additional days.
- Employee assistance program for well-being and support.
- On-site gym and wellness facilities.
- Professional development and continuous learning opportunities.
- Subsidised canteen and free parking.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
⚠️ Important Disclaimer
Welcome to Courierser Jobs. We publish job opportunities aggregated from public sources, employers, and job portals. We never charge any fees to access or use our website; all information is provided entirely for free.
Courierser Jobs does not directly offer or manage these positions, nor are we directly involved in the hiring process for the vacancies published on https://couriersers.org.
If you suspect a fraudulent listing or have any questions, please contact us at techturna@gmail.com.