Head of Regulatory Affairs
Salary undisclosed
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Executive recruitment company Monroe Consulting Group Indonesia is recruiting on behalf of a Multinational Pharmaceutical - Consumer Health Company for the role of Regulatory Affairs Head.
The job description will be as follow :
- Lead product registration, regulatory submissions, and compliance with local and international regulations.
- Collaborate with internal teams, external partners, and regulatory authorities to ensure timely approvals and regulatory updates.
- Monitor evolving regulatory requirements and implement necessary adjustments to maintain compliance.
- Drive the development and launch of new products, ensuring alignment with technical, regulatory, and market needs.
- Evaluate product feasibility, manage project timelines, and oversee the execution of launch strategies.
- Ensure adherence to rigorous quality control measures, conducting audits and managing external testing.
- Maintain compliance with product licenses, regulatory requirements, and operational guidelines for storage and distribution.
- Identify and address quality concerns with manufacturers and suppliers to maintain product integrity.
- Work closely with internal teams and external partners (e.g., manufacturers, suppliers, regulatory authorities) to drive seamless operations and ensure product excellence.
Qualifications & Experience
- Bachelor’s degree in Pharmacy, Life Sciences, or a related field (advanced degrees preferred).
- 10+ years of experience in Pharmaceuticals, OTC, Medical Devices, or Healthcare.
- Proven track record in project management, new product development, product management, regulatory affairs, and product launches.
- Strong understanding of pharmaceutical/OTC/medical device product development and regulatory requirements.
- Exceptional leadership, strategic planning, and problem-solving skills.
- Ability to work effectively in a fast-paced environment, managing multiple projects and deadlines.
- Excellent communication and relationship-building skills to collaborate with cross-functional teams.