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Your tasks and responsibilities
The primary responsibilities of this role, Associate Director, Global Regulatory Strategy, CMC are to:
Represents global RA CMC in various cross-functional teams, including CMC development teams, product supply teams, global regulatory teams;
Responsibility 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, and country RA functions, 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;
Responsibility for timely availability and final CMC content of IND/IMPD, NDA/BLA/MAA, or supplemental submissions for assigned products and product portfolio to Health Authorities, including responses to health authority questions;
Responsibility for CMC change management evaluation for assigned development and marketed products. Responsible for compiling variation packages and coordination of responses to health authority questions;
Collaboration 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;
Responsibility 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;
Ensures adequate surveillance of the CMC related regulatory environment, particularly for assigned biotechnology and pharmaceutical products, and anticipates and influences changes in this environment globally.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Leading Pharmaceutical Company seeks an incumbent who possesses the following:
Advanced technical degree Ph.D., DVM or Pharm D in life sciences preferred 6 years in medical research activities of which 1-3 years include local/ global regulatory experience, or MS degree with 8 years of medical research activities of which 3-5 years include local/global regulatory experience, or BS degree with 10 years of medical research activities of which 5-10 years include local/global regulatory experience;
Excellent oral and written communication skills;
Ability to work within a global team framework and a multi-cultural environment;
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;
Goods problem-solving skills as applicable to drug regulatory issues, and preferably experience in dealing with Drug Regulatory Bodies;
Strong analytical skills and well-developed project management skills;
The position requires scientific and technical expertise, including the ability to develop/execute robust regulatory strategies, timelines and action plans.
Knowledge of biotech and/or gene therapy development is a plus;
Knowledge of drug regulations and guidance documents on drug development and license variations in ICH countries is preferred;
Knowledge of regulatory expectations in non-ICH regions is desirable
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