Regulatory Affairs Manager

2 days ago

Singapore JUNIPER BIOLOGICS PTE. LTD. Full time

**Position Summary**

Provide comprehensive regulatory support and focusing on the successful registration and lifecycle management of products in the APAC region. This role involves collaborating with regulatory partners and distributors to ensure regulatory compliance, license renewals, and successful market entry for new products. Additionally, the individual will contribute to the development and implementation of regulatory strategies, offer guidance to stakeholders, and ensure compliance with relevant regulations. This position includes reviewing, compiling, and submitting New Drug Applications (NDAs) and variations to the Singapore Health Sciences Authority (HSA), as well as coordinating regulatory activities, audits, and external engagements across multiple markets.

**Job Descriptions**
- Provide regulatory support to Group Regulatory Affair Director
- Work with regulatory partners/distributors to obtain successful registration of new products.
- Work with regulatory partners/distributors for life cycle management of existing products to ensure regulatory compliance and licence renewals to support business needs.
- Contribute to development and implement of regulatory strategies for new products and changes to existing products in line with business objectives
- Provide regulatory advice and inputs where necessary with stakeholders
- Review, compile and submit NDAs and variations to Singapore HSA
- Coordinate, facilitate, monitor, and track all regulatory activities in each market, including but not limited to audits, external engagement with regulatory agencies.
- Contribute to develop and maintain policy, standard operating procedure or local working practices.
- Ensure regulatory compliance in all regulatory processes.
- Stay up to date on regulatory changes in the region
- Any other duties assigned

**Qualifications/Requirements**
- Minimum Degree holder in pharmacy, biological sciences or life sciences and other related disciplines.
- Min 3-5 years regulatory experience in Regulatory Affairs and preferably in the pharmaceutical industry.
- Proactive, team spirit, motivated and self-starter
- Registered pharmacist is an advantage
- Ability to prioritize workload and work independently yet collaboratively
- Project management skills
- Good written and verbal communication skills

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