Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Are you ready to advance your career with a highly dynamic team? Thermo Fisher Scientific Inc. seeks a Specialist in CMC Regulatory Affairs. Join our world-class organization and help us make the world healthier, cleaner, and safer. This is your chance to be part of a team that values innovation, collaboration, and excellence!
Responsibilities
- Author and prepare global CMC variation submissions, annual reports and renewals, tender applications, and GMP submissions
- Comply strictly with client’s technical information requirements and timelines
- Provide packages for internal client review, update as needed, and deliver finalized packages for publishing and QC
- Update internal systems (RIMS, Publishing, eDMS) or documentation as required
- Support requests for information from Health Authorities or partners
- Work closely with other departments, regulatory consultants, and regulatory authorities
- Identify and acknowledge out-of-scope activities in contracts promptly and coordinate with other departments to effectively carry out contract modifications
Required Skills and Qualifications
Education
- University degree or equivalent experience in life sciences or related health sciences (BS/BA/MS or comparable)
- A Degree or equivalent experience in Regulatory Affairs is beneficial
Experience
- At least 2 years of experience in the biotech or pharmaceutical sector, with a minimum of 2 years specifically in Regulatory Affairs CMC
- Experience in life sciences, particularly in biological, vaccines, small molecule, or gene therapy medicinal products, is beneficial
- Proven regulatory CMC authoring skills with the ability to evaluate technical and scientific CMC information for accuracy and compliance
Technical Skills
- Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva, Documentum), and Change Management (e.g., Trackwise) systems
- Proficiency in Microsoft Office
Proficiencies
- Excellent communication, project management, planning, and problem-solving skills
- Strong great teammate with a demonstrated ability to develop constructive and effective relationships with peers and management
- Outstanding organizational and follow-up skills, with strong attention to detail
- Ability to work independently with sound technical and analytical judgment
- Flexibility to thrive in a global cross-cultural work environment
- Proficient in English and the local language