Regulatory Affairs Manager

**Title**:
Regulatory Affairs Manager (SG/MY & Alliance Markets)

**Company**:
Ipsen Pharma Singapore PTE. LTD.

The person is responsible for implementing and managing strategies and tactics regarding product registration and life cycle management for the International Business division in Singapore and managing Regulatory Operations in Malaysia via the appointed service provider. The incumbent must ensure the full implementation of the regulatory matters and adherence to local and global standards.

**Main responsibilities**

Regulatory Affairs
- Implement regulatory strategic planning according to Corporate Regulatory Affairs’ policy and SG/MY & Alliances Market business objectives.
- Integrate input from relevant department from time to time to ensure alignment with RA strategic plan.
- Manage a comprehensive regulatory activity database and provide update to the commercial team as and when.
- Coordinate, file and monitor new registration and variation submissions for existing and new products, in collaboration with business strategies and local regulations.
- Implement strategies and tactics to expedite approvals.
- Stay current on official legislation and orientate team members to understand implications and impact on overall business.
- Develop, coordinate and provide technical and legal documentation as required/requested by the importing markets, including hospital tender listing.
- Develop and maintain a close working relationship with Global and Regional RA as well local commercial team.
- Develop and maintain a professional relationship with the government officials at the drug regulatory agencies.
- Revise finish artwork of packing materials according to the local regulatory requirements and manage any amendments with department involved.
- Assist Partners to set up local inspections/joint inspections with local health authorities for Good Manufacturing Practices certification.
- Develop effective working relationship with Global RA, Affiliate Regulatory Managers and Partner Regulatory managers.
- Where needed, lead MA transfer to a designated third party by engaging all necessary stakeholders.

Management of Regulatory Service Provider
- Establish working relationship and close collaboration with RA service provider for assigned territory.
- Develop submission plans and timelines with partner and ensure Ipsen product dossiers and packaging materials are up-to-date and in compliance with local regulations.
- Ensure Ipsen has visibility of all regulatory information and upcoming changes in the local regulatory landscape.
- Work with both commercial and supply chain team to ensure smooth operation when implementing regulatory changes, new promotional material, or a new requirement.
- Support potential tenders or hospital listing by ensuring renewal of required documents as well having it readily available.
- Be the GRA contact point for the said territory.

Compliance and Governance
- Observe overall compliance of specifications of products to those the registration in all standard operation procedures.
- Participate in meetings at industry associations on regulatory matters.
- Represent the company against unfair competition of product advertisement.
- Assume special projects or duties as assigned by management.
- Participate in Regulatory industry conferences to stay updated with the current policy, opportunities and issues.
- Observe overall compliance of specifications of products to those the registration in all standard operation procedures.
- Participate in meetings at industry associations on regulatory matters.
- Represent the company against unfair competition of product advertisement.
- Assume special projects or duties as assigned by management.
- Participate in Regulatory industry conferences to stay updated with the current policy, opportunities and issues.
- Review promotional material for regulatory compliance.

Ad Hoc Projects/Duties assigned
- Special projects/tasks in conjunction with the APAC/Global Regulatory team as required.

We are looking for a passionate incumbent to join us. You should possess the following requirements to succeed in the role:

- Minimum: Bachelor’s Degree in Pharmaceutical Sciences
- Eligible/Qualified to hold Pharmacist License
- Minimum 3 to 5 years of experience in Regulatory Affairs in affiliate set up.
- Thorough knowledge of regulatory requirements in Singapore & Malaysia and Alliance market including Pharmacovigilance requirements.
- Experience working as a Regulator is a plus point.
- Fluent in spoken and written English