Bayer Associate Director, Global Chemistry, Manufacturing and Controls Strategy in Morristown, New Jersey
Your tasks and responsibilities
The primary responsibilities of this role, Associate Director, Global Chemistry, Manufacturing and Controls Strategy, areto:
Provide leadership for the development of Chemistry, Manufacturing and Controls(CMC) Regulatory strategy for new product development projects;
Work with Development Teams to ensure the on-time compilation of high quality Common Technical Document(CTD) Module III and Quality Overall Summary (QOS) documents;
Participate in Technical Sub-Teams for new product development projects as a core team member;
Define, in collaboration with Regulatory Strategy, the CMC requirements in order to register new products;
Maintain knowledge of current industry requirements and standards for CTD Module III and QOS or equivalent;
Draft or update the technical registration dossiers (CTD Module III and QOS or equivalent) of pharmaceutical products;
Manage the dossier change requests (including manufacturing site transfers) of pharmaceutical products;
Lead the development of technical documents for variation files;
Act as liaison between Local Regulatory Affairs and sites to request information and resolve any issues regarding assigned product portfolio.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
Bachelor’s degree with 10 or more years of proven experience; or
Master’s degree with eight (8) or more years of proven experience; or
Ph.D. with postdoctoral work or six (6) or more years of proven experience;
Significant experience in global CMC/Module 3 creation;
Demonstrated track record of successfully leading projects and teams;
Experience dealing with global regulatory authorizes.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.