This role involves managing and compiling CMC sections for marketed product variations to ensure timely submission documentation.
Responsibilities include collaborating with regulatory and functional teams to develop module content, maintaining accuracy and completeness of dossiers, and facilitating review meetings.
Qualifications required are a Bachelor's degree in science with 5+ years of pharmaceutical experience, including regulatory affairs or R&D, and 1-2 years of project management.
Candidate should have strong communication skills, experience with electronic document systems, and knowledge of US and international regulatory requirements.
Ability to work independently, manage multiple projects, and adapt to changing priorities is essential.