Associate Director Global Regulatory Affairs Biotech Chemistry Manufacturing and Control
Your tasks and responsibilities
The primary responsibilities of this role, Associate Director, Global Regulatory Affairs Biotech Chemistry Manufacturing and Control, are to:
- Represent global Regulatory Affairs (RA) Chemistry Manufacturing and Controls (CMC) in various cross-functional teams, including CMC development teams, product supply teams, global regulatory teams;
- Have responsibility for the regulatory strategy with regard to CMC for assigned products and product portfolio in close cooperation with the relevant global, regional, and country RA functions, Bayer Healthcare (BHC) Product Supply, Quality, Medical, and Marketing to ensure early identification of major regulatory hurdles and issues. Provides active input into Global Regulatory Teams for assigned projects to ensure timely submission and first cycle approval;
- Be responsible for timely availability and final CMC content of IND/IMPD, BLA/MAA-, or sBLA-submissions for assigned products and product portfolio to Health Authorities, including responses to Health Authority questions;
- Be responsible for CMC change management evaluation for assigned development and marketed products. Responsible for compiling variation packages and coordination of responses to health authority questions;
- Collaborate with CMC Managers, Senior Managers, and Specialists to ensure close alignment of CMC activities across the Therapeutic Area groups;
- Proposes and implements standards concerning CMC documentation in close co-operation with global, regional, and local RA functions, and BHC Product Supply;
- Be responsible for achieving assigned global regulatory affairs project objectives for assigned products and product portfolio using effective oral, written, and presentation skills. The ability to deal with critical and/or sensitive issues with internal and external customer groups will be required;
- Ensure adequate surveillance of the CMC- related regulatory environment, particularly for assigned biotechnology pharmaceutical products, and anticipates and influences changes in this environment globally.
- Relocation assistance is being provided. Up to 10% overnight international travel.
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:
- Ph.D., Pharm D. or equivalent scientific degree with 8 years pharmaceutical industry experience (preferably within development biotechnology functions) including 3 years of relevant RA experience OR Masters of Science degree in life sciences with 10 years pharmaceutical industry experience (preferably within development biotechnology functions) OR Bachelor of Science degree in life sciences with 12 years pharmaceutical industry experience (preferably within development biotechnology functions), which includes 7 years of relevant RA experience;
- Fluent in English;
- Excellent oral and written communication skills;
- Ability to work within a global team framework and a multi-cultural environment. As job holder has to work directly with different hierarchical levels within BHC, ability to establish relationships between individual departments is essential. The job holder must be able to absorb large amounts of information efficiently and give sound judgments to manage difficult situations effectively;
- Ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment often under time pressure;
- Incumbent must have good knowledge of the pharmaceutical industry, general business practices and processes;
- Good problem-solving skills as applicable to drug regulatory issues;
- Strong analytical skills and well developed project management skills;
- Scientific and technical expertise, including the ability to develop/execute robust regulatory strategies, timelines and action plans.
- Knowledge of other languages (i.e. German);
- RA experience with biotech products/devices, including but not limited to antibody drug conjugate development (ADC);
- Knowledge of gene therapy development;
- Experience in dealing with Drug Regulatory Bodies;
- Knowledge of drug regulations and guidance documents on drug development and license variations in ICH countries;
- Knowledge of regulatory expectations in non-ICH regions.
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.