Regulatory Affairs Manager
Takeda · Singapore, Singapore ·
- Employment
- Full time
- Category
- Legal
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Job Description
Job Summary:
The talent will manage Regulatory Affairs for all Company products in Singapore to ensure they are in compliance with statutory and company requirements and maximize the contribution of Regulatory Affairs to the achievement of business objectives through active assistance in the development and implementation of the company’s policy positions and product advocacy strategies.
Key Responsibilities:
Regulatory Affairs
- RA registered pharmacist for Singapore LOC
- Plan, strategize and monitor regulatory filings for timely submissions and approvals of new product registrations and variation applications.
- Life cycle management of existing product portfolio while ensuring smooth supply of products
- Manage labeling changes, safety updates, artwork development and artwork approval of packaging material components.
- Build effective working relations with the regulatory agency and follow-up closed on approval of products registration and variations
- Work with all appropriate local functions to develop and implement the best regulatory strategies/plans to support commercial goals and product launch excellence.
- Develop annual regulatory budget for Singapore filings/variations/registrations/license renewals.
- Review promotional material in relation to product campaign launches and ongoing product marketing activities.
- Support regulatory review or artwork/promo material/ad-hoc requests for partners’ products
- Update and maintain local and global-associated databases with Singapore regulatory information.
- Keep tracking of policy changes, current and emerging issues, understand their potential impact on business and build corresponding strategies to support business
- Develop and maintain good and effective relations with local authorities and pharmaceutical associations
- Participate in local authority inspections and internal audits when applicable to the regulatory affairs function.
- Assist Head of Regulatory Affairs, MYSG on regulatory assignments as and when required.
Responsible Person for Takeda Pharmaceuticals Asia Pacific (TPAP)
- Appointed as Responsible Person and named in the import licence and wholesale licence.
- Responsible for implementing and maintaining an effective quality system that meets GDP standard
- Has adequate knowledge on the GDP-related activities to be carried out and the procedures to be performed under the licence.
- Has training in GDP, understands the GDP requirements for effective quality system to meet GDP Standard
Preferred Skills and Qualifications:
- Registered Pharmacist in Singapore
- Minimum Bachelor's Degree in Pharmacy
- A minimum of 5 to 7 years of relevant Regulatory Affairs expertise in the pharmaceutical industry
- Experience in Oncology, Vaccines, Rare Diseases, Gastroenterology or Neroscience is an advantage.
- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
- Knowledge of national legislation and regulations relating to medicinal products
- Holder of controlled drugs license complying to HSA regulations
- Prior face to face interaction with HSA is an advantage
- Experience in Access Consortium Submissions in Singapore is an advantage