Regulatory Affairs Manager

3 days ago

Central Region, Singapore ALLIED SEARCH PTE. LTD. Full time $104,000 - $130,878 per year
  • Opportunities for professional development
  • Reputable organization
  • Good company benefits

As an Regulatory Affairs Manager (Chinese Proprietary Medicine), you will be responsible for the following duties:

  • Serve as the primary point of contact between the company and regulatory authorities (e.g., Health Sciences Authority) to oversee and support product registration, certification, and application processes for market entry. Ensure ongoing license maintenance (e.g., Marketing Authorizations) aligns with local regulatory requirements and that corporate regulatory systems, SOPs, and procedures are effectively implemented.
  • Compile and organize technical documentation, product details, and ensure all materials related to product registration, manufacturing, and marketing adhere to Singapore's regulatory standards.
  • Build and maintain strong working relationships with key external regulatory agencies; coordinate and attend meetings, and engage in regulatory negotiations as needed.
  • Manage and ensure regulatory compliance for pharmaceutical exports from China to Singapore in accordance with relevant export regulations.
  • Support internal teams by conducting research and evaluation of proprietary Chinese medicine formulas, and provide regulatory insights and consultation.

Requirements:

  • Master's degree or above in Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, or a related field.
  • At least 5 years of working experience is required, with 2 years of drug registration experience.
  • Preferably a registered pharmacist with the Singapore Pharmacy Council, would be advantageous. Proprietary Chinese medicines is preferred.
  • Proven ability to manage regulatory issues.
  • Knowledge of regulatory environment and how this impacts regulatory strategy and implementation.
  • Knowledge of drug development practice, rules, regulations and guidelines.

To apply, simply click on the "apply" button in the job advertisement or alternatively, you can send in your resume via email: .COM.SG

We regret to inform that only shortlisted candidates will be notified.

ALLIED SEARCH PTE. LTD.

EA LICENSE : 19C9777

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