Manager, Commercial Regulatory Affairs
Location:
Lawrence Township , New Jersey
Posted:
September 08, 2017
Reference:
1703239

About Bristol-Myers Squibb:
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.


Description:
The primary responsibility of a manager in Commercial Regulatory Affairs is to provide expert and strategic regulatory advice and risk assessment on promotional issues with guidance from management to ensure that BMS implements product promotion consistent with BMS policies, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidance’s.



Responsibilities include:

  • 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 guidances.

  • 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

Qualifications:
Qualifications:
  • 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.

A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.

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