This is an exciting new role with a global biotech company at a pivotal stage of its growth. the role will be focused on global RA projects associated with late stage clinical to regulatory approval stage.
- Contributes to the development and evaluation of regulatory strategies for supporting clinical trials with focus in the Asia Pacific and the EU regions
- Provides regulatory support to inter-departmental project teams.
- Works with global regulatory team members to agree contents for timely submissions to Health Authorities.
- Responsible for coordinating the preparation and regulatory review of documents for regulatory submissions from all areas of the company.
- Ensures that data provided are presented clearly and succinctly to optimize the regulatory review and approval process.
- Directs the activities of and interacts with other departments in the preparation of initial INDs, CTAs, and regulatory dossiers for marketing applications.
- Liaise with health authorities as needed (e.g. submissions, telephone contacts, teleconferences, meetings).
- Coordinates the preparation of responses to questions and inquiries from Health Authorities. Prepares and submits amendments, safety reports and annual reports etc. in accordance with regulatory submission schedules and regulations.
- Keeps employees informed of relevant regulatory guidance documents, regulations and information.
- Other responsibilities, as required.
- Bachelors or advanced degree (Ph.D. or Pharm.D.) in scientific/life-sciences or related field.
- Minimum of 8 years' experience in regulatory affairs.
- Oncology and biologic/cell therapy experience is highly preferred.
- Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with Asia/EU Regulatory Authorities
Please send your resume in WORD format by clicking the apply button below or contact Jochen Surrey on +65 6701 1516 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878834 (Jochen Nico Surrey).