Job title: Regulatory Affairs Specialist
Job type: Permanent
Emp type: Full-time
Industry: Life Science and Healthcare
Salary type: Annual
Salary: negotiable
Job published: 2025-05-30
Job ID: 96321
Contact name: Michael Chu
Phone number: +85239150280
Contact email: michael.chu@linksinternational.com

Job Description

Regulatory Affairs Specialist – Healthcare OTC Consumer Products

Are you passionate about compliance and ensuring consumer health products meet regulatory standards? Join our team as a Regulatory Affairs Specialist specializing in Healthcare over-the-counter (OTC) consumer products!

Your Role:

✔ Ensure regulatory compliance for OTC consumer healthcare products, including supplements, personal care items, and non-prescription medications.
✔ Prepare and submit documentation for product approvals, licenses, and labeling requirements, ensuring adherence to government regulations.
✔ Collaborate with R&D, marketing, and quality assurance teams to integrate regulatory considerations into product development.
✔ Manage cross-border regulatory requirements for international product distribution.
✔ Conduct internal audits and assist in regulatory inspections when necessary.
✔ Stay up to date with evolving regulations and ensure timely implementation within the organization.
✔ Provide regulatory guidance on product claims, advertising, packaging, and promotional materials.
✔ Maintain accurate documentation and records for regulatory affairs activities.
✔ Research and analyze industry trends and new regulatory updates to support compliance strategies.

What You Need:

🔹 Experience: 1–2 years experience in regulatory affairs, preferably OTC consumer products, healthcare, or FMCG industries.
🔹 Education: Degree in life sciences (e.g., Biology, Biochemistry) or a related field.

Key Skills & Attributes:

  • Strong regulatory knowledge of OTC consumer goods, labeling, and compliance standards.
  • Excellent communication skills to liaise with regulatory authorities and internal teams.
  • Collaborative team player working across departments like R&D, QA, and marketing.
  • Adaptability in a fast-changing regulatory environment.
  • Attention to Detail in reviewing compliance-related documentation.
  • Critical Thinking to assess challenges and recommend solutions.
  • Time Management for meeting submission deadlines and regulatory requirements.
  • High ethical standards to maintain compliance integrity in consumer health products.

Why Join Us?

✅ Work with innovative OTC consumer products that impact everyday health and wellness.
✅ Collaborate with industry-leading professionals in regulatory affairs.
✅ Advance your career in a dynamic and evolving sector.

Are you ready to make a difference in regulatory compliance for consumer healthcare? Apply now and be part of a team dedicated to ensuring safe, compliant, and high-quality OTC products!