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Regulatory Affairs Associate Director

SGD12000 to SGD15000 per month + AWS +Bonus

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.

Responsibilities

  • 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.

Requirements

  • 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).

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  • Singapore
  • Permanent
  • Wed Sep 18 03:44:25 2019
  • BBBH7089