Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Office

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

Skills Required