Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Responsibilities
- Authoring and preparation of: global CMC variation submissions, annual reports and renewals, tender applications, and GMP submissions
- Comply with client’s technical information to be provided and timelines
- Provide packages for internal client review and update these as needed
- Provide finalized packages for publishing and QC published output
- Update of internal systems (RIMS, Publishing, eDMS) or documentation as needed
- Support requests for information from HAs or from partners
- Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
- Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
General required skills and qualification
Education:
- University degree in life sciences or related health sciences (BS/BA/MS or equivalent), a degree in Regulatory Affairs is advantageous.
Experience:
- Minimum of 2 years’ experience in the biotech or pharmaceutical industry, with at least 2 years in Regulatory Affairs CMC.
- Knowledge in life sciences with a focus on biological/vaccines/small molecule/gene therapy medicinal products is an advantage.
- Strong regulatory CMC authoring skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements.
- Knowledge in Good Manufacturing Practice or related areas.
Technical skills
- Must be familiar and able to work with RIMS (e.g Veeva RIMS), eDMS (e.g. Veeva, Documentum) and Change Management (e.g. Trackwise) systems.
- Microsoft Office skills.
Competencies:
- Excellent communication, project management, planning and problem solving
- Strong team player with a demonstrated ability to develop constructive and effective relationships with peers and management
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to work with minimal supervision based on sound technical and analytical judgment
- Flexibility to work in a global cross-cultural work environment
- Fluent in English and local language