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Regulatory Affairs - Promotional AD
Ref No.: 19-14808
Location: Summit, New Jersey
Sunrise System Inc. is currently looking for Regulatory Affairs - Promotional AD in Summit, NJ with one of our top client.
Job Title: Regulatory Affairs - Promotional AD
Job Id: 19-14808
Location: Summit, NJ 07901
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
 
Summary/Scope
Responsibilities will include, but are not limited to, the following:
  • Supports interactions with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) for assigned product(s).
  • With oversight from Director level or above, develop regulatory strategies and provide guidance to other departments.
  • Manage timelines and resources to achieve stated goals.
  • Foster and facilitate teamwork between regulatory, legal, medical and commercial colleagues participating the Promotional Review (PACT) process.
  • Assess regulatory risk and develop mitigation strategies with oversight.
  • Provide regulatory advice and support to commercial teams and (PACT), with oversight.
  • Develop departmental guidance and procedures.
  • Manage regulatory aspects of the copy review / approval process for product promotional materialsfor assigned products, indications, or audiences.
    Ensure compliance of promotional materials with the governing FDA regulations, and ensure submission of promotional materials to OPDP in a timely fashion.
  • Design and conduct departmental training
  • Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Client's pharmaceutical products.
  • Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape.
Key Requirements/Knowledge
  • Bachelor’s degree (BA or BS). Scientific discipline preferred.
  • 3-7 years of pharmaceutical industry experience, including 2-4 years in regulatory affairs.
  • Knowledge of FDA advertising and promotional regulations and guidance is necessary.
  • Must be able to innovate, analyze, and solve problems with minimal supervisory input.
  • Excellent communications, listening, and negotiation skills are necessary.
  • Leadership skills required.
  • Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.
  • Must be an innovator of new ideas and best practices
  • Must recognize potential problems
  • Must have outstanding attention to detail. 
Contact
Savitha Divakaran
Direct: (732) 272 0299 | Email: Savitha.D@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com