About the Company
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 over the next 10 years. Our products are delivered to people in more than 150 countries. We are a company where outstanding people are at the heart of everything we do.
Job Description
We are seeking a highly motivated and experienced Regulatory Affairs Manager to join our dynamic team in Westminster, London. This pivotal role will be responsible for leading regulatory strategies, submissions, and compliance activities for our innovative pharmaceutical products across various therapeutic areas. The successful candidate will navigate complex regulatory landscapes, ensuring timely approvals and ongoing adherence to global health authority requirements. This is an exciting opportunity to contribute to bringing life-changing medicines to patients worldwide.
Key Responsibilities
- Develop and execute regulatory strategies for new product development and lifecycle management.
- Prepare, review, and submit high-quality regulatory dossiers (e.g., MAA, variations, renewals) to global health authorities.
- Act as the primary contact point for regulatory agencies on assigned projects.
- Interpret and communicate regulatory requirements to cross-functional teams, ensuring compliance throughout product development.
- Manage regulatory aspects of product labeling, promotional materials, and post-market commitments.
- Monitor global regulatory intelligence and assess impact on current and future product portfolios.
- Lead regulatory projects and initiatives, ensuring adherence to timelines and quality standards.
- Participate in due diligence activities for business development opportunities.
Required Skills
- Proven experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of EU and UK regulatory requirements for pharmaceutical products.
- Strong understanding of product lifecycle management.
- Excellent written and verbal communication skills.
- Ability to work collaboratively in a cross-functional team environment.
- Demonstrated project management and organizational skills.
- Attention to detail and analytical problem-solving abilities.
Preferred Qualifications
- Bachelor's degree or higher in a scientific discipline (e.g., Pharmacy, Chemistry, Biology).
- Experience with electronic submission systems (e.g., eCTD).
- Experience in specific therapeutic areas such as Oncology, Immunology, or Respiratory.
- Knowledge of other major global regulatory requirements (e.g., FDA, ICH guidelines).
Perks & Benefits
- Competitive annual salary and bonus scheme.
- Generous pension plan contributions.
- Comprehensive health and wellbeing benefits package.
- Flexible working arrangements (hybrid model).
- Opportunities for professional development and career growth.
- Access to a global network of scientific and industry experts.
- Employee assistance program.
- On-site fitness and wellness facilities.
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.
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