Specialist CMC Regulatory Affairs

Work Schedule

Environmental Conditions

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 clients 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