About the Company
At Roche Diagnostics, we are driven by a singular purpose: to transform healthcare with innovative diagnostic solutions. As a global leader in in-vitro diagnostics, we empower healthcare professionals to make faster, more informed decisions, ultimately improving patient outcomes. Our pioneering spirit and commitment to scientific excellence have shaped the future of medicine for over a century. We foster a diverse and inclusive environment where every voice contributes to our shared mission of making a real difference in people’s lives.
Job Description
We are seeking an accomplished and strategic Regulatory Affairs Manager to join our dynamic team. This pivotal role will be instrumental in guiding our pharmaceutical and medical device products through complex international regulatory landscapes. You will develop and execute global regulatory strategies, ensuring timely approvals and sustained compliance across multiple markets. This position offers international sponsorship for qualified candidates, reflecting our commitment to attracting world-class talent from around the globe. Based in our Norwich office, this is a hybrid role, balancing collaborative in-office work with flexible remote options.
Key Responsibilities
- Develop and implement comprehensive global regulatory strategies for pharmaceutical and medical device products.
- Lead the preparation, submission, and maintenance of regulatory dossiers, applications, and registrations to health authorities worldwide.
- Serve as the primary liaison with regulatory agencies, addressing inquiries and negotiating approvals.
- Monitor, interpret, and communicate changes in global regulatory requirements, assessing their impact on company products and operations.
- Ensure all product development, manufacturing, and commercial activities comply with applicable regulations (e.g., FDA, EMA, MHRA, TGA, Health Canada, EU MDR/IVDR).
- Manage and mentor junior regulatory affairs professionals and project teams.
- Participate in product lifecycle management, including change control assessments and post-market surveillance.
- Conduct regulatory due diligence for new product acquisitions or partnerships.
Required Skills
- Proven experience as a Regulatory Affairs professional within the pharmaceutical or medical device industry.
- In-depth knowledge of global regulatory frameworks, including FDA, EMA, and other major health authority requirements.
- Demonstrated expertise in preparing and submitting regulatory documents (e.g., INDs, NDAs, BLAs, 510(k)s, PMAs, CE Mark applications).
- Strong analytical, problem-solving, and decision-making abilities.
- Excellent written and verbal communication skills, suitable for interactions with regulatory agencies and cross-functional teams.
- Ability to manage multiple projects concurrently and prioritize effectively in a fast-paced environment.
- Bachelor's degree in a scientific or health-related field (e.g., Pharmacy, Chemistry, Biology, Biomedical Engineering).
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific discipline.
- Regulatory Affairs Certification (RAC).
- Experience with advanced therapies, biologics, or complex diagnostic devices.
- Prior experience in managing a team of regulatory professionals.
- Fluency in additional languages relevant to key international markets.
Perks & Benefits
- Competitive annual salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans.
- Generous pension scheme with company contributions.
- Relocation assistance and full international sponsorship for eligible candidates.
- Extensive professional development opportunities and tuition reimbursement.
- Flexible hybrid work model, promoting work-life balance.
- Employee assistance programs and wellness initiatives.
- Opportunities for global collaboration and career progression within a leading multinational corporation.
- Paid time off, including holidays and sick leave.
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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