Director, Regulatory Affairs: Advertising and Promotional Review

24 Jul, 2021

Jobs

Director, Regulatory Affairs: Advertising and Promotional Review

Novavax
Gaithersburg, MD

Job Details

Description

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

We are seeking a highly motivated and experienced individual for a Director position to lead and build a Promotional Review Team within our Regulatory Affairs organization. This position is located at our Gaithersburg, MD facility and will report to the Vice President of Regulatory Affairs. This position will develop, manage, and execute global promotional strategies working in close collaboration with cross-functional teams across the organization.

Responsibilities include but are not limited to:

The Director of Advertising and Promotional Review has the following responsibilities:

  • Directs or assists staff member(s) or independently reviews and approves content required for advertising and ensures promotional materials are in regulatory compliance with relevant laws and regulations as well as company policies and procedures to communicate proper use and safety of products within promotional materials.
  • Supervises direct and indirect report(s) or analyses and interprets new regulations and FDA guidance documents as well as monitors and determines the impact of Office of Prescription Drug Promotion or Advertising (OPDP) correspondences and enforcement actions.
  • Acts as liaison between the company and OPDP. Arranges and leads meetings and interactions with OPDP as appropriate.
  • Leads submission for advisory comments and provides strategic advice for the development of packages to be sent to OPDP as appropriate.
  • Manages review of promotional materials and sets priorities to ensure internal and external deadlines are met.
  • Identify and assist teams in overcoming barriers and finding solutions in achieving quality and compliance.
  • Communicates labeling update plans to commercial and other functional teams in a timely manner.
  • Oversee the development of any internal documents related to product labeling including but not limited to Policies, Standard Operating Procedures (SOPs) and Work Practices as needed.
  • Ensures all actions taken within this role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained.
  • Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.
  • Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic areas.
  • Provides training to employees on regulations regarding advertising and promotion compliance as appropriate.
  • Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.

 

Minimum requirements:

  • Life sciences, pharmacy graduate or equivalent. Advanced academic qualifications/degree such as Pharm.D. or Ph.D. are an advantage but not essential.
  • A minimum of 12 years in the drug development industry with at least 10 years in Regulatory Affairs with focus on Advertising and Promotion expertise.
  • Proven ability to successfully understand regulatory implications of product strategy with regards to the product labeling, assessment and practical management of associated impacts.
  • Demonstrated ability to interpret and apply global and local regulatory guidance around promotion and associated supportive documentation, both in the pre-approval and post-approval (maintenance) stages.
  • Proven aptitude to analyze and interpret scientific data.
  • Experience in communicating and negotiating with APLB or OPDP.
  • Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.

 

Key skills and competencies:

  • Knowledge of global/regional regulations and guidelines pertaining to advertising and promotion materials and activities and demonstrated ability to decipher and understand implications of labeling changes on pending and approved products across regions.
  • The candidate must demonstrate a high level of understanding of labeling and promotion compliance.
  • Demonstrated ability to understand how updating one section of a labeling may impact promotional materials.
  • Able and willing to work in a fast-paced environment while handling multiple priorities and deal with ambiguity.
  • Shows strong initiative and drive. Must be an organized self-starter.
  • Strong written and verbal communication skills essential.
  • Demonstrated project management skills and attention to detail required.
  • Strong computer skills possessing a good understanding on the use of technological systems and processes.
  • Proven ability to negotiate, influence and problem solve across a highly matrixed team.
  • Must be effective in managing workload and resolving conflicts.

 

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

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Job posted: 2021-07-24