Senior Director, Regulatory Affairs: Global Advertising and Promotion

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Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

 

Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform.  Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

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

Summary of the Position:

We are seeking a highly motivated and experienced individual for a Senior Director, Regulatory Affairs, Global Advertising and Promotion position to lead and build a global group within our Regulatory Affairs organization. This position will report to the Vice President of Regulatory Affairs. This position will develop, manage, and execute global advertising and promotion strategy working in close collaboration with cross-functional teams across the organization. 

This position will report to the Vice President of Regulatory Affairs, operating out of Switzerland.  Remote based candidates will be considered local to the office.

Responsibilities include but are not limited to:

The Senior Director Regulatory Affairs, Global Advertising and Promotion has the following responsibilities:

  • Oversee/ensure commercial and promotional materials are consistent with international laws and guiding principles
  • Directs/provides regulatory review of advertising and promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.
  • Oversees/Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies.
  • Manages local activity including enforcement actions, guidance documents, etc. to analyze and assess impact on company products and communicates risk to medical, legal and compliance teams.
  • Monitors competitor advertising to keep abreast of market promotional and advertising strategies and assesses potentially violative competitive materials
  • Continually assesses advertising and promotion - related processes and procedures to enhance efficiencies and compliance.
  • Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion.
  • Assures that promotional PIs and Important Safety Information are updated as appropriate. Other job responsibilities as needed: Communicates label update plans in a timely manner.
  • Facilitates 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.
  • Lead training for Commercial teams on regulations of advertising and promotion
  • Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.
  • Works closely with US based Global reviewers to ensure consistency and compliance
  • Other task/assignments may be delegated

Minimum requirements:

  • Advanced academic qualifications/degree such as Pharm.D., Ph.D. are an advantage but not essential.
  • A minimum of 15 years in the drug development industry with at least 10 years in Regulatory Affairs prescription product advertising and promotion expertise
  • Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts.
  • Demonstrated ability to interpret and apply global and local regulatory guidance around advertising and promotions and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
  • Excellent communication skills, both oral and written
  • Strong interpersonal skills with the ability to influence others, without authority, in a positive and effective manner
  • Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
  • Proven aptitude to analyze and interpret efficacy and safety data
  • Experience communicating and negotiating with regulatory authorities
  • Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
  • Excellent written and verbal communication skills essential.
  • Demonstrated project management skills and attention to detail required.
  • Proven ability to negotiate, influence and problem solve across a highly matrixed team.
  • Ability to travel (domestic and international) up to 10%

Key Skills and Competencies:

  • Knowledge of global/regional regulations and guidelines pertaining to Advertising and Promotions and demonstrated ability to decipher and understand implications of regulation changes and updates
  • Demonstrated knowledge and understanding of company Core Data Sheets, Core Safety Information documents and the dynamics of Labeling Team purpose and objectives.
  • Able and willing to work in a fast-paced environment while handling multiple priorities.
  • Shows strong initiative and drive. Must be an organized self-starter.

Every day our employees impact the future of health by preventing disease. To recognize their contributions, we offer them performance-based pay; a flexible, welcoming work environment; comprehensive and competitive benefits.

Novavax is headquartered in Gaithersburg, Maryland. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals 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 protected characteristic.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Job details
Regulatory Affairs
Remote - Europe
Zurich, Zurich, CHE
ASSOC003333
Full-time
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