Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Associate Director Global CMC Regulatory Documentation

Your tasks and responsibilities

 

The primary responsibilities of this role, Associate Director Global CMC Regulatory Documentation, are to:

 

  • Provide leadership for the development of CMC strategy for new product development projects;
  • Be skilled in providing regulatory assessments and developing regulatory strategies for successful global CMC submissions;
  • Develop extensive experience with regulatory filings including NDAs, INDs, sNDAs, MAAs, IMPDs, DMFs and variations;
  • Work with Development Teams to ensure the on-time compilation of high quality CTD Module 3 and QOS documents;
  • Be a core team member of Technical Sub-Teams for new product development projects;
  • Develop, 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 3 and QOS or equivalent;
  • Provide CMC leadership and guidance to the project teams in the efforts to register existing products in new markets by identifying filing requirements, gaps & risks, and proposing mitigation plans;
  • Manage post-approval changes to the CMC dossier including change controls and dossier maintenance;
  • Prepare CMC variations, expert statements and supplemental NDAs to register product changes;
  • Update the technical registration dossiers (CTD Module 3 and QOS or equivalent) of registered consumer products;
  • Manage product change requests (including manufacturing site transfers) of registered consumer products;
  • Lead the development of technical documents for variation files;
  • Resolve any CMC issues and queries received from regulatory agencies regarding the 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:

 

Required Qualifications:

 

  • Bachelor’s degree with ten or more years of proven experience, Master’s degree with six or more years of proven experience, or Ph.D. with postdoctoral work or four or more years of proven experience;
  • Accomplished CMC Regulatory Professional with extensive experience in the pharmaceutical industry managing prescription, OTC, and generic drugs;
  • Significant experience in global CMC/Module 3 creation;
  • Track record of successfully leading projects and teams;
  • Experienced working in the US regulatory environment (NDAs, INDs, ANDAs & sNDAs).

Your application

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.

 

Country: United States
Location: NJ-Morristown