Job Description

Job Responsibility : Primary Responsibilities: This job description is intended to provide a general overview ofthe job requirements at the time it was prepared. The job requirements of any position maychange over time and may include additional responsibilities not specifically described in thejob description. Consult with your supervision regarding your actual job responsibilities andany 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 by

interpretation of applicable laws, regulations and guidance\xe2\x80\x99s, 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