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Associate Director, Regulatory Advertising and Promotion

Waltham, MA

ABOUT US

There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.

At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Our proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering, designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs).

Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.

Be part of making a difference. Be part of Invivyd.

Position Summary:  Associate Director, Regulatory Advertising and Promotion

The Associate Director, Regulatory Advertising and Promotion will be responsible for leading, reviewing and approving strategies for non-promotional and promotional materials to comply with regulatory requirements throughout the product life cycle.  In this role, you will be responsible for ensuring compliance with regulatory agencies requirements and Invivyd’s promotional, medical, and corporate communications objectives.  Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new regulations and guidance documents.

The AD, Regulatory and Promotion will also coordinate regulatory training pertaining to advertising, promotion, and product launch activities.  The individual will work collaboratively with medical affairs, legal, compliance, and commercial teams in the development and implementation of advertising and promotional processes and materials for Invivyd’s product portfolio. 

Responsibilities:

  • Maintain a deep and current awareness of evolving US and global regulations and guidelines, enforcement actions and policy issues affecting the pharmaceutical/biotech Industry.
  • Provide regulatory input into the development, review, approval, and implementation process for promotional and non-promotional materials review in a cross-functional environment.
  • Effectively partner with Medical Affairs, Legal, Compliance, Commercial, and other stakeholders as needed to ensure that promotional and non-promotional materials and are reviewed in a timely fashion throughout the product life cycle.
  • Interpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and management.
  • Ensure communications and promotional claims are consistent with product registrations, applicable laws, regulations and policies and have sufficient substantiating evidence.
  • Coordinate regulatory training on regulatory issues pertaining to advertisement and promotion activities.

Requirements:

  • Doctorate, Master's, or Bachelor's degree in a relevant/scientific discipline (graduate degree preferred)
  • Minimum of eight years working in the  pharmaceutical or biotech industry with a minimum of 4 years in Regulatory Affairs
  • Experience working with OPDP.
  • Thorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotion.
  • Knowledge of global drug/biologic regulations and standards particularly related to promotion including but not limited to EU and international requirements is a plus.
  • Ability to work in a fast-paced, environment where drive is critical to success.
  • Ability to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence across all business functions in order to reach resolution.
  • Strong writing, project management and communication skills.

Invivyd is proud to be an equal opportunity employer.

We do not accept unsolicited resumes from agencies. 

 

We do not accept unsolicited resumes from agencies. 

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