
Manager, Regulatory Affairs
7 days ago
**About Juniper Biologics
Juniper Biologics is a science led healthcare company focused on delivering novel therapies to improve the health and quality of life of patients, by building a growing presence in Oncology, Rare/Orphan Diseases and Gene Therapy.
Our company, work and people span jurisdictions, cultures and languages. In a world where commercial success increasingly relies on globalisation, we offer our people a rewarding and stimulating career. To that end, this role can be based anywhere as we are happy to adopt a remote way of working. We're proud of our entrepreneurial and team-based way of working.
**Key Responsibilities**
- Provide regulatory support to Regional RA 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 advertising/promotional materials and procedures to ensure regulatory compliance
- 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, life sciences or other related disciplines
- Min 5 years’ regulatory experience in Regulatory Affairs and preferably in the pharmaceutical or related industry
- Proactive, team spirit, motivated and self-starter
- Knowledge/ working experience for MEA market is an advantage
- 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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