Regulatory Manager/Senior Manager - Consumer Healthcare
Robert Walters Thailand
An excellent Regulatory Affairs Manager job under consumer healthcare has just become available at one of the world's leading pharmaceutical companies.
About the Regulatory Affairs Manager Role:
Reporting directly to the Regional Regulatory Affairs Leader, you will be responsible for all regulatory activities looking after Thailand and Vietnam's entire consumer healthcare portfolio.
- Follow up with regulatory environment in the country and distributor markets as applicable
- Provide support in the analysis of business development opportunities to ensure provision of high quality due diligence activities for business and/or product acquisitions and geographical expansion
- Lead the countries regulatory activities and provide leadership, strategic direction, clear objectives / priorities and managerial oversight
- Provide regulatory solutions for launches in various consumer healthcare categories such as OTC, health supplements and fortified food with claims
- Manage registration plans and ensure objectives for new registrations in the country are aligned with commercial objectives and priorities
- Provide oversight of life cycle management to ensure maintenance of the licenses and compliance
- Manage regulatory issues and CAPA's within the company and at the FDA level as require
- Develop strong working / partnering relationships with the countries agency
- Represent the Consumer Healthcare Business Regulatory Organisation internally and externally within the country
- Oversee and ensure full compliance and conformance with all government regulations, requirements and guidelines in the country
To succeed in the Regulatory Affairs Manager job, you will need to have the ability to work effectively and cooperatively with cross-functional teams, across borders and internal matrix.
- Minimum seven to ten years' experience in Regulatory Affairs
- Regulatory experience with consumer health products required such as drugs, health supplements and food
- Experience in Rx drugs, medical devices and cosmetics will be an advantage
- Demonstrable experience across drug development and commercialisation lifecycle with proven examples of contribution
- Experience in R&D / medical / clinical / technical areas are preferable
- Regulatory experience including knowledge of regulatory requirements, application submission processes and product life cycle management activities for various consumer product categories in the country
- Demonstrable experience of consistent, effective and timely delivery of objectives (cost and quality standards)
- Have successfully developed regulatory strategies and manage / prioritise regulatory issues and mitigation
This international pharmaceutical company needs no introduction and is recognised as the leader in their field of expertise. The culture is demanding but if you are confident and have a can-do attitude the potential rewards are significant. The company is also very focused on developing and training their people to the highest standards.
If you are driven, determined and want to take the next step in your career, this is the role for you. Great career progression opportunities await the right person in this exciting Regulatory Affairs Manager job.
Apply now for this great opportunity.
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Robert Walters Thailand
Established in 1985, Robert Walters plc is a world-leading specialist professional recruitment consultancy and the core brand of the Group. Hiring managers world-wide rely on us to find their best specialist professionals and our clients range from the largest corporates world-wide through to SMEs and start ups. We recruit people for permanent, contract and interim roles across the world.