Manager Regulatory Affair at Capgemini Engineering coordinating activities for the US market. Preparing submissions to the FDA and collaborating with internal teams for regulatory compliance.
About the role
- Senior Manager providing strategic regulatory advice for promotional issues at Bristol Myers Squibb. Ensuring compliance with policies, guidelines, and regulations relevant to pharmaceutical promotion.
Responsibilities
- Provide regulatory advice and risk assessment on concepts and final advertising/promotional materials, sales training materials, and external communications for marketed products, as assigned.
- Assure full regulatory compliance of all promotions with approved labeling and FDA guidance.
- Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals.
- Build a strong relationship with internal customers; including Commercial, Legal and Medical.
- Begin to develop relationships with OPDP.
- Prepare communications with guidance for OPDP concerning sub part e and advisory submissions.
- Ensure timely and accurate submission of promotional materials to OPDP on Form 2253.
- Participate in review of product labeling submissions.
- Works with management to ensure that changes in US PI are reflected in current promotions and advertising.
- Handle other duties and/or special projects as assigned.
Requirements
- Bachelors Life Science degree required; advanced degree preferred (MS, PhD, PharmD, or JD).
- Candidate should have a minimum of 1-2 years Regulatory promotional review experience.
- Candidate should have experience providing strategic direction to interdisciplinary teams on promotional materials activities for marketed products and strong interest in FDA advertising and promotional practice regulations including guidance(s).
- Broad “hands on” related pharmaceutical experience (prefer 5 years pharmaceutical industry experience) and actual FDA regulatory experience.
- Detail & deadline oriented; well organized.
- Excellent verbal and written communication skills.
- Good interpersonal skills; ability to interact with staff on all levels.
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*.
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