Associate Director,Regulatory Compliance
- Establishes worldwide policy for drugs of abuse (controlled drugs) and controlled chemicals. These policies act as minimum standards. Assess compliance to these policies and to the more country specific requirements.
- Establish and direct multifaceted compliance program for drugs and chemicals controlled by the U.S. Drug Enforcement Administration. The requirements are set forth in Title 21, Code of Federal Regulations (CFR) parts 1300 to end. This position is responsible for interpreting DEA laws and regulations, establishing and maintaining policy, determining and providing counsel related to compliance with these requirements, and representing AbbVie in both written and verbal communications with govern
- Directs program to provide source of expertise within the corporation regarding Alcohol and Tobacco Tax and Trade Bureau (TTB) requirements set forth in Title 27, Code of Federal Regulation (CFR) Chapter 1. The program requires interpreting laws and regulations, establishing and maintaining corporate policy, determining and providing counsel for resolving AbbVie compliance with these requirements, and representing AbbVie in both written and verbal communications with government officials.
- Establishes Food Facility registrations and supports the Regulatory function in Establishment Registration (Drug and Device), and Drug/Device Listing.
- Serve as AbbVie's contact for regulatory agency communications involving DEA and TTB, and develop liaison and rapport with agency personnel at all levels. These relations are critical to compliance understanding between AbbVie and the agencies and greatly impact the degree of cooperation extended. This position establishes AbbVie's identity with these outside agencies.
- Manage the Inspection Administrator function for DEA and TTB audits of all domestic AbbVie facilities. Further, if necessary, provide a written response to DEA / TTB observations and follow-up to insure that proper action is taken.
- Establish and maintain AbbVie's identity with outside peer groups by representing AbbVie at professional organization seminars and meetings with regard to controlled drugs and controlled chemicals.
- Provide guidance and input into Office of Ethics and Compliance (OEC) and Human Resources (HR) employment decisions relative to violations of controlled drug laws, regulations, policies and procedures.
- Provide consulting services with regard to controlled drugs and chemicals.
- B.S. or advanced degree in chemistry, biology or related science required.
- Minimum 9 years' experience in the pharmaceutical / biopharmaceutical industry and 5 years direct experience with DEA/FDA/TTB regulations required.
- Ability to work effectively with various technical groups and a strong working knowledge in one or more of the following disciplines: API or drug product manufacturing, pharmaceutical sciences, analytical development / QC labs, GLP requirements.
- Proven management skills with ability to lead others effectively and experience to advocate a compliant environment
- Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs) and/or Good Distribution Practices (GDPs).
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates good verbal, written, and interpersonal communication skills.
- Demonstrates proficiency in Microsoft Office applications.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic .