Regulatory Affairs professional is responsible for ensuring a company's products and practices comply with relevant regulations by interpreting and applying legal guidelines, preparing and submitting necessary documentation to regulatory agencies, communicating with authorities, and advising internal teams on regulatory compliance throughout the product development and marketing process; requiring a deep understanding of regulations, strong analytical skills, meticulous attention to detail, and excellent communication abilities to navigate complex regulatory landscapes.
Key Responsibilities:
1. Regulatory Submissions:
- Prepare, review, and submit high-quality regulatory documents, including new drug applications (NDAs), variations, renewals, and post-approval changes, in compliance with HSA requirements.
- Ensure timely and accurate submission of regulatory filings in the respective markets (Asia) by working closely with CRO’s and appointed pharmaceutical distributors’ in-market RA team to meet business objectives.
2. Drug Licensing:
- Lead the end-to-end drug licensing process, including the preparation of product dossiers, labeling, and packaging materials.
- Liaise with HSA and other regulatory authorities to address queries and facilitate the approval process.
3. Compliance and Strategy:
- Stay updated on changes in regulatory guidelines and ensure company practices align with local and international regulations.
- Provide regulatory intelligence and strategic advice to internal stakeholders to support product development and commercialization.
4. Cross-Functional Collaboration:
- Work closely with R&D, Quality Assurance, Pharmacovigilance, and Commercial teams to ensure regulatory requirements are integrated into product development and marketing strategies.
- Support the preparation of regulatory responses during audits and inspections.
5. Documentation and Record-Keeping:
- Maintain accurate and up-to-date regulatory documentation and databases.
- Ensure proper archiving of regulatory submissions and correspondence.
Requirements:
-Bachelor’s degree in Pharmacy, Life Sciences, or a related field. Advanced degrees(e.g., MSc, PhD) are a plus.
- Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of HSA regulations, ICH guidelines, and ASEAN regulatory requirements.
- Proven track record of successful drug licensing and product registration in Singapore.
- Strong understanding of pharmaceutical product development, manufacturing, and quality systems.
- Ability to work independently and manage multiple projects in a fast-paced environment.
