Manager / Associate Director, Regulatory Affairs
2 weeks ago
Review promotional claims and materials for BI Rx drug promotion for compliance with Food Drug Cosmetic Act (FDCA) and for consistency with product labeling. Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications. Review scientific exchange communications that require HPRC approval to ensure they are free from graphics and text representations that imply product promotion.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
**Duties & Responsibilities**:
- Review and approval of promotional communications for conformance to product labeling and regulations related to Rx drug promotion. Reviews reflect appropriate risk assessments.
- Knowledge and understanding of drug development, including phases of clinical studies, general requirements for drug marketing approval and basic statistics.
- Knowledge and adoption of Accountability, Agility and Intrapreneurship within HPRC through seeking opportunities by which to improve HPRC processes or the quality of promotional materials for BI Rx drugs.
- Knowledgeable of the FDCA and its implementing regulations in 21 CFR. Identify and routinely monitor reliable sources from which to obtain product and/or regulatory information.
- Review and signature of FDA forms 2253 with approved promotional communications.
**Requirements**:
- Bachelors degree in life science or degree in the legal field (e.g., lawyer, para-legal) from an accredited institution.
- Advanced degree preferred.
- Persons with a non-science degree having relevant professional experience may be considered.
- Associate Director level: must have three to five (3-5) years of experience in the pharmaceutical industry with experience in Regulatory Affairs.
- Manager level: must have (1-3) years of experience in the pharmaceutical industry, preferably in Regulatory or Medical Affairs.
- Specific experience in regulatory advertising and promotion is preferred.
- Work history of successful participation of deliverables within a team matrix.
- Persons in this role must have excellent communication skills both verbal and written.
- All roles in US regulatory advertising and promotion require complete fluency in the English language as word choices and phraseology are particularly important in Rx drug promotion.
- Must have knowledge of drug development process and ability to assess biostatistics and clinical studies with respect to the support of clinical claims. Must have excellent written and verbal skills as the role will be required to interact with and influence other disciplines involved in BI promotion review.**Eligibility Requirements**:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
**Compensation**:
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