Job Description

US Advertising/Promotion Regulatory Reviewer

Purpose :

- The purpose of the US Advertising/Promotion Regulatory Reviewer- role is to deliver accurate, balanced, and substantiated product and disease communications for assigned assets.

- The US Advertising/Promotion Regulatory Reviewer partners across teams to advise on regulatory requirements and expectations for compliant communications.

- The Regulatory Reviewer also supports process excellence related to FDA submission activities for promotional materials.

Primary Responsibilities :

- This job description is intended to provide a general overview of the job requirements at the time it was prepared.

- The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

- Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position

Regulatory Expertise :

- Review promotional tactics and internal field-based communications

- Serve as Regulatory representative for US brand teams for promotional tactics and internal field-based communications

- Provide high quality, timely and decisive regulatory advice that enables business partners to make well-informed decisions

- Ability to interpret product claim instructions and ensure appropriate implementation in final promotional tactics

- Communicate regulator expectations by utilizing OPDP feedback received , interpretation of applicable laws, regulations and guidance\'s, and knowledge of FDA enforcement actions.

- Contribute to business risk mitigation strategies related to advertising, promotion

- Provide regulatory advice consistent with Customer Information Quality (CIQ) system requirements and processes

- Build, maintain, and leverage relationships with team members to effectively influence the implementation of appropriate communications.

Process Excellence :

- Provide timely and quality review of 2253 promotional material submissions to FDA for assigned marketed products

- Provide timely and quality review of FDA advisory comment submission materials

- Support direct to distribution workflow (E.g., sample cartons, monthly social media submissions)

- Prepare and/or review VVPM submission binders for 2253 and advisory comment submissions

- Manage expedited submission requests related to promotional materials, coordinating with RDE as needed

- Manage FDA correspondence templates including periodic reviews and revisions as needed

- Draft FDA correspondence letters, as requested

- Support electronic archival in RIM for FDA incoming correspondence and Records of Contact

- Monitor external Federal Register notifications related to OPDP research; facilitate internal discussions and commenting on proposed research, as needed

- Manage advertising/promotion SharePoint site to facilitate shared learning (e.g., training resources, SWAT assessments, etc.)

- Support data on file activities related to publishing syntax

Deviation Management and Change Control :

- Provide timely completion of impact assessments for deviation management and input into change controls for assigned marketed product, consulting with Indy[1]based team as needed

Collaborate with other Regulatory colleagues :

- Partner with US Regulatory Scientist and Labeling Operations to manage labeling revisions to balance consideration of business implication and regulatory compliance

- Partner with US-based Ad/Promo Regulatory Reviewers to develop and implement product discontinuation plans, including determination if safety claims are impacted and determining timing for updates

- Communicate and share key information to enable seamless execution of US regulatory strategy and promotional activity

- Partner with US-based team to support special projects related to advertising/promotion

Lead/Influence/Partner :

- Exemplify Team behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions

- Models the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.

- Constructively challenge teams to reach the best solutions to issues

- Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions

Minimum Qualification Requirements :

- Master\'s Degree in a scientific or health sciences discipline (or equivalent experience)

- Demonstrated ability to influence without authority and ability to deliver multiple complex projects against a timeline.

- Demonstrated ability to work in a global environment

- Strong English communication skills (active listening, verbal, and written)

- Demonstrated ability to apply systematic thinking/mindset to business problems and opportunities

- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

- Strong attention to detail

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