Job Description
Position: Regulatory Affairs Specialist – Healthcare OTC Consumer Products
Our client, a leading healthcare organization, is seeking a Regulatory Affairs Specialist to ensure compliance and regulatory excellence across their portfolio of over-the-counter (OTC) consumer health products, including supplements, personal care items, and non-prescription medications. This role offers a dynamic career path in a fast-evolving sector, where your expertise will directly contribute to the safety, quality, and market success of everyday health solutions.
If you are passionate about regulatory compliance and eager to make a meaningful impact in consumer healthcare, this is a fantastic opportunity to grow your career in a collaborative and innovation-driven environment.
Key Responsibilities
- Lead regulatory submissions and ensure compliance for OTC consumer healthcare products across local and international markets.
- Prepare and manage documentation for product approvals, licenses, and labeling in accordance with government regulations.
- Collaborate with cross-functional teams including R&D, marketing, and quality assurance to integrate regulatory strategies into product development.
- Monitor and implement changes in regulatory requirements, ensuring timely updates and compliance.
- Provide guidance on product claims, advertising, packaging, and promotional materials.
- Support internal audits and assist during regulatory inspections.
- Maintain accurate records and regulatory documentation.
- Research industry trends and regulatory updates to inform compliance strategies.
Key Requirements
- Education: Degree in Life Sciences (e.g., Biology, Biochemistry) or a related field.
- Experience: 1–2 years in regulatory affairs, ideally within OTC consumer products, healthcare, or FMCG industries. Fresh Graduates are welcome too.
- Skills & Attributes:
- Strong understanding of OTC regulatory frameworks and labeling standards.
- Excellent communication and collaboration skills.
- Detail-oriented with strong organizational and time management abilities.
- Adaptable and proactive in a fast-changing regulatory environment.
- High ethical standards and critical thinking in compliance decision-making.
What’s Next?
If you're ready to contribute to the future of consumer healthcare and thrive in a regulatory role, we invite you to apply. Alternatively, send your latest CV to tiffany.wong@linksinternational.com for a confidential career discussion and insights into the Hong Kong healthcare market.