Overview As Regulatory Manager you will shape regulatory strategy for clinical trials, agency meetings, orphan designations, pediatric planning, and accelerated pathways. You will coordinate regulatory documents for authorities and ethics committees, and guide cross-functional teams through the clinical development life cycle. You'll keep regulatory intelligence updated and ensure submissions are timely and of high quality. This role offers impact across regional and global programs within a compliance-focused environment.
Responsibilities- Develop and guide regulatory strategy for clinical development and regulatory submissions
- Coordinate preparation of documents for submission to Regulatory Authorities and Ethics Committees
- Lead and participate in regulatory authority meetings and scientific advice procedures
- Prepare and review regulatory submissions (CTA/IND, annual reports, amendments, orphan designations, pediatric planning)
- Represent Global Regulatory Affairs in project teams and coordinate regional/global submissions
- Maintain project plans, trackers, and regulatory intelligence tools
- Support development of Regulatory Affairs staff and provide input on study opportunities and timelines
- Contribute to corporate quality initiatives and ensure adherence to regulatory standards
- Provide ICH GCP guidance and training to internal/external clients
- Travel domestically and internationally as needed
- Motivate teams to meet timelines and manage multiple tasks in fast-moving environments
- Focus on process improvement and data quality in regulatory activities
Key requirements- Bachelor's degree in a scientific or healthcare discipline
- 7 years regulatory experience for Senior Manager level
- Regulatory affairs experience in a Clinical Research Organisation
- Experience leading clinical submissions
- In-depth knowledge of drug development process and regulatory milestones (EU, US) including INDs/CTAs, scientific advice procedures, and post-approval submissions
- Understanding of clinical trials methodology and study protocols
- Strong interpersonal and teamwork skills with a professional and service-oriented mindset
- Ability to manage multiple tasks, maintain records, and deliver commitments on time
- Self-motivated, independent, and able to work in a team environment
- Excellent English communication, both written and verbal
- Strong interpersonal skills
- Team collaboration
- Professionalism and reliability
- Regulatory strategy development
- Clinical submissions leadership (CTA/IND)
- Regulatory intelligence and tracking tools
