Regional Regulatory Affairs Manager
- Regional exposure with strong hands-on ownership - Pharma & Consumer Health portfolio - Dare to lead and drive regional decisions independently.
Job Overview:
Lead regional regulatory strategies across export markets to ensure timely product registrations, lifecycle management, and full compliance with local and international regulations. Act as a key regulatory business partner to support commercial objectives while collaborating closely with global teams and external distributors.
Key Responsibilities:
Qualifications
Lead regional regulatory strategies across export markets to ensure timely product registrations, lifecycle management, and full compliance with local and international regulations. Act as a key regulatory business partner to support commercial objectives while collaborating closely with global teams and external distributors.
Key Responsibilities:
- Develop and drive regional regulatory strategies to ensure timely submissions and approvals for new product registrations, renewals, and post-approval variations in export markets.
- Ensure full compliance with local regulations, international standards, and global regulatory strategies aligned with business objectives.
- Collaborate closely with Commercial, Medical Affairs, Marketing, and Supply Chain to integrate regulatory considerations into regional initiatives.
- Partner with external distributors to expedite approvals and maintain effective relationships with Health Authorities across the region.
- Monitor regulatory landscape changes, assess risks and opportunities, and proactively mitigate potential business impact.
- Lead and coordinate regulatory submission activities including dossier preparation, variations (safety, CMC, labeling, packaging), and lifecycle management.
- Ensure artwork and labeling compliance with country-specific requirements and coordinate packaging updates with global and regional stakeholders.
- Review promotional and non-promotional materials to ensure regulatory compliance.
- Maintain regulatory databases and tracking tools to ensure transparency and deadline adherence.
- Support marketing authorization transfers, rebranding projects, and other regulatory initiatives as assigned.
- Manage regulatory budget and external vendor coordination in partnership with Finance.
Qualifications
- 8+ years regional Regulatory Affairs experience in pharmaceutical, consumer healthcare, or medical device industry.
- Degree in Health Sciences or Pharmacy preferred.
- Experience managing multi-country submissions and working with distributors.
- Strong stakeholder management, analytical skills, and ability to work in a matrix environment.
- Fluent English communication.
About Us
Wenetwork Asia is a specialized executive search firm focusing on Healthcare and Life Sciences across the region. We are currently acting on behalf of our client to identify a high-caliber professional for this opportunity.
If you are interested in exploring this role confidentially, please apply this opportunity via this portal. All applications will be review and get in touch handled with strict confidentiality.
Wenetwork Asia is a specialized executive search firm focusing on Healthcare and Life Sciences across the region. We are currently acting on behalf of our client to identify a high-caliber professional for this opportunity.
If you are interested in exploring this role confidentially, please apply this opportunity via this portal. All applications will be review and get in touch handled with strict confidentiality.
Referral reward: Rp5000000