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
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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