Regulatory Affairs Manager (S.E.A)

Location Singapore
Discipline Life Sciences
Job Reference BBBH109159_1642041299
Salary S$8000 - S$10000 per month
Consultant Name Wee Ben Ann, Andy
Consultant Email
Consultant Contact No. 62328831
EA License No. 02C3423
Consultant Registration No. R1552080

Job Description

  • Provide regulatory guidance to the S.E.A business that have major impact on strategy of new launches of various products including chemicals, excipients.
  • Manage entire spectrum of regulatory work including product registration and licensing.
  • Interaction with local regulatory authorities such as NEA, HSA, SPF, SCDF, SFA, Singapore Customs as well as overseas partners pertaining to regulatory activities, including registrations, variations to existing products, renewals, application of advertisement, etc.
  • Evaluation, compilation, preparation of registration dossiers.
  • Manage compliance of products in accordance with existing regulations and guidelines.
  • Resolve licensing and registration issues to allow products to be sold.
  • Implement procedures to ensure compliance with all applicable license as per define product portfolios such as but not limited to Chemicals, Consumables, Equipment, BioPharma products and Medical Devices.
  • Responsible for coordination and preparation of regulatory submissions and strategies.
  • Develop and maintain regulatory knowledge of Singapore regulations as well as export markets.
  • Manage the final product and license submissions and negotiate and communicate effectively with regulatory authorities to obtain timely product and license approvals.
  • Participate in product teams about implementation of regulatory requirements.
  • Manage transposition of international standards into company product related requirements.
  • Provide the Project teams with regulatory input to obtain timely regulatory approvals for the products as part of the product development planning.

Job Responsibilities

  • Degree in Life Sciences / Pharmacy or related fields.
  • Minimum of 8 years of relevant working experience in regulatory and compliance.
  • Prior experience within the Life Sciences / Pharmaceutical / Chemical industries will be highly advantageous.
  • Prior exposure in S.E.A regulations and compliance will be advantageous.
  • Comfortable working in a fast-paced environment.
  • Possess excellent interpersonal and communication skills.

Andy, Wee Ben Ann License No.: 02C3423 Personnel Registration No.: R1552080

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