The role involves authoring regulatory submissions, collaborating with departments, and managing compliance in CMC for biotech products.
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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
Top Skills
Documentum
Edms
MS Office
Rims
Trackwise
Veeva
Thermo Fisher Scientific Chennai, Tamil Nadu, IND Office
Sun Centre, No. 2, Tank Bund Rd, Nungambakkam, Chennai, Tamil Nadu, India, 600034
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