1700 advertising - Bengaluru, India - Recruise India Consulting Pvt Ltd
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
- Ability to interpret product claim instructions and ensure appropriate
- Communicate regulator expectations by utilizing OPDP feedback received by
enforcement actions.
- Contribute to business risk mitigation strategies related to advertising, promotion
- Provide regulatory advice consistent with Customer Information Quality (CIQ) system
- Build, maintain, and leverage relationships with team members to effectively
Process Excellence
- Provide timely and quality review of 2253 promotional material submissions to FDA
- Provide timely and quality review of FDA advisory comment submission materials
- Support direct to distribution workflow (E.g., sample cartons, monthly social media
- Prepare and/or review VVPM submission binders for 2253 and advisory comment
- Manage expedited submission requests related to promotional materials,
- Manage FDA correspondence templates including periodic reviews and revisions as
- Draft FDA correspondence letters, as requested
- Support electronic archival in RIM for FDA incoming correspondence and Records of
- Monitor external Federal Register notifications related to OPDP research; facilitate
- Manage advertising/promotion SharePoint site to facilitate shared learning (e.g.,
- Support data on file activities related to publishing syntax
Deviation Management and Change Control
- Provide timely completion of impact assessments for deviation management and
Collaborate with other Regulatory colleagues
- Partner with US Regulatory Scientist and Labeling Operations to manage labeling
- Partner with USbased Ad/Promo Regulatory Reviewers to develop and implement
and determining timing for updates
- Communicate and share key information to enable seamless execution of US
Regulatory strategy and promotional activity
- Partner with USbased team to support special projects related to
Lead/Influence/Partner
- Exemplify Team behaviors: Include, Innovate, Accelerate, Deliver in internal and
- Models the innovation and leadership behaviors and regulatory excellence attributes
- Constructively challenge teams to reach the best solutions to issues
- Create and lead in an environment that encourages open discussions on issues to
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