- Stay updated on regulatory changes and assess their impact on the business and products.
- Communicate updates on HSA and APAC regulations to regional/global RA and commercial teams.
- Develop registration strategies, timelines, and risk mitigation plans for assigned products/projects.
- Manage new product submissions, lifecycle variations, and cross-functional collaboration to meet regulatory requirements.
- Prepare and maintain local SOPs and policies in line with global and local regulations.
- Provide regulatory support for marketing plans, product launches, and promotional material reviews to ensure compliance.
- Maintain strong relationships and negotiate with the Health Sciences Authority (HSA) to secure timely approvals.
- Represent APAC RA in project teams and address regulatory agency queries.
- Ensure accuracy and quality of regulatory documentation and strategic submissions.
- Monitor project progress, identify delays, and recommend improvements to accelerate timelines.
Job Requirements:
- A bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related field
- Minimum of 5 years of regulatory experience in the pharmaceutical industry, covering OTC, health supplements, pharmaceuticals, and vaccines.
- Must be a Singapore-registered Pharmacist with access to PRISM (HSA online system).
- Regional regulatory affairs (RA) experience or exposure is highly desirable.
- Strong strategic and conceptual thinking skills, with an entrepreneurial mindset and the ability to prioritize effectively.
- Demonstrates agility, initiative, integrity, and the ability to anticipate potential issues, coupled with proposing mitigation strategies.
- Meticulous with attention to detail and capable of navigating ambiguities.
- Proven leadership skills and experience working collaboratively across functions, levels, and managing projects.
- Proficiency in English, both spoken and written, with the ability to communicate effectively with all management levels and across diverse cultural backgrounds.
- Comprehensive knowledge of local and APAC regulations.
- Excellent interpersonal, communication, and negotiation abilities.
Location : Bugis
Interested applicants please send your resume to [email protected]
We regret that only short-listed candidates will be notified.
PERSOLKELLY Singapore Pte Ltd EA License No. 01C4394 I RCB No. 200007268E EA Reg. No. R1107631
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