Associate Director/ Director, Regulatory Affairs:

vor 19 Stunden

Zurich, Schweiz Novavax, Inc. Vollzeit

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

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. 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.

**Summary of the Position**:
We are seeking a highly motivated and experienced individual for a Director/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.

**Responsibilities include but are not limited to**:
The Associate Director/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 12 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.
- 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 compa

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