YOUR TASKS AND RESPONSIBILITIES
In Bayer's Pharmaceuticals division, we focus on researching, developing, and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology, and ophthalmology. With our innovative products, we seek to achieve therapeutic benefit for patients, while at the same time satisfying the growing requirements of physicians and health insurers. As one of the leading research-based pharmaceutical companies worldwide, we have nearly 50 ongoing development projects in clinical trials.
The primary responsibilities of this role, Associate Director RA CMC, are to:
- Be responsible for the regulatory strategy with regard to Chemistry Manufacturing and Controls (CMC) for assigned products and product portfolio in close cooperation with the relevant global, regional, andcountry RA (Regulatory Affairs) functions, Product Supply, Quality, Medical, and Marketing toensure early identification and mitigation of major regulatory hurdles and issues;
- Represent global RA CMC in various cross functional teams, including CMC development teams, product supply teams, global regulatory teams;
- Provide 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 (Investigative New Drug/ Investigational Medicinal Product Dossier), NDA/BLA/MAA (New Drug Application/Bayer Leadership Academy Biologics License Application/ Market Authorization Application) submissions for assigned products to Health Authorities, including responses to health authority questions;
- Be responsible for CMC change management evaluation for assigned products;
- Mentor less experienced / newcomers within the RA CMC organization and drive close alignment of CMC activities across groups;
- Propose and implement standards concerning CMC documentation in close co operation with global, regional, and local RA functions, and Product Supply;
- Be responsible for achieving assigned global regulatory affairs project objectives;
- Ensure adequate surveillance of the CMC related regulatory environment and anticipate and influence changes in this environment.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, Efficiency) values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Bachelor of Science degree in Life Sciences
- Scientific and technical expertise in pharmaceutical development;
- Ability to develop robust regulatory strategy, timelines and action plans;
- Knowledge of drug regulations and guidance documents on drug development, license submissions and variations in all main countries;
- Have thorough knowledge of the pharmaceutical industry and regulatory affairs experience with pharmaceutical products;
- Be able to work focused and target oriented in a complex scientific / technical environment;
- Good analytical skills, and well developed project management skills;
- Well developed interpersonal skills, ability to work within a global team framework and a multi cultural environment;
- Incumbent has to work directly with different hierarchical levels, ability to establish relationships between individual departments;
- Fluent in English with good oral and written communication skills.
- Five years of relevant RA experience.
- Ph.D, or equivalent Scientific Degree with six years Pharmaceutical Industry experience including three years of relevant RA experience; Or Master of Science degree in a Life Sciences field with eight yearsPharmaceutical Industry experience which includes five years of relevant RA experience; OrBachelor of Science degree in Life Sciences with 10 years Pharmaceutical Industry experience.