Our client is a niche Regulatory consulting firm which provides the highest-level Regulatory expertise to a variety of biotech and pharmaceutical clients. They are seeking a Regulatory Affairs Advertising & Promotions Principal Consultant who can provide leadership on advertising and promotional materials for various client projects. You will be responsible for the daily management of regulatory requirements for Advertising & Promotions and serve as a subject matter expert. This is a remote role where you will work closely with exciting biopharma clients and collaborate internally with a team of biopharmaceutical leaders and innovators. This company offers a competitive salary, comprehensive employee benefits, and the ability to work from home. Now is an exciting time to join this dynamic and growing organization!
Responsibilities
- Daily management of regulatory requirements for advertising and promotions for one or more client projects.
- Review and evaluate materials submitted by client teams to ensure that the content, quality, and format comply with applicable laws, regulations, and client policy.
- Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory strategy, process, filing, best practices, etc. in conjunction with client leadership.
- Provide strategic and operational leadership for promotional, educational, and investigative communications.
- Use extensive knowledge of country-specific regulatory requirements (US, EU and ICH) and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support clients' corporate goals.
- Manage launch preparation of promotional material for one or more products.
- Provide support and guidance to regulatory teams on RA requirements for one or more drug products.
- Maintain knowledge of changing regulatory requirements and advise teams as appropriate.
- Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.
Qualifications
- Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD PharmD, or PhD) preferred.
- Must have a minimum of 7 years of experience in pharmaceutical regulatory affairs specializing in Advertising & Promotions.
- Must have experience reviewing promotional materials across a variety of platforms (print, TV, online, DTC, etc)
- Prior experience with product launches is required. Experience with Accelerated Approvals highly desired.
- Experience working directly with OPDP is a must. Experience with APLB is a plus, but not required.
- Prior experience with payer materials and medical affairs required.
- Experience across multiple therapeutic areas is a plus, and experience with oncology and/or rare disease areas is highly desired.
- US experience is required and global/international experience is desired.
- Must have experience working with Veeva for management of promotional materials.
- Proven project management skills to support the planning and coordination of regulatory submissions and appropriate regulatory inspections.
- Ability to work independently and innovatively in tackling operational challenges.
- Must be collaborative and work well with clients.
This is a remote position with some occasional travel for client meetings. The budgeted salary range for this position is $240,000 to $275,000 plus a quarterly bonus program and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.
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