For The Candidates

Director, Regulatory Labeling & Promotional Compliance

POSITION SUMMARY

This individual is expected to provide leadership within the Regulatory Affairs Labeling and Promotional Compliance group and will be responsible for actively contributing to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. This person will serve as the Regulatory Labeling representative on relevant project teams, and as a Regulatory contact with DDMAC for assigned products.

DUTIES & RESPONSIBILITIES

Directs the regulatory labeling activities of programs and professionals

Chairs the Labeling Working Group

Represents Regulatory on the Promotional Material Review Team (PMRT) and is accountable for ensuring that all promotional materials and activities are compliant with promotional/advertising regulations and healthcare authority guidances.

Accountable for development and execution of global regulatory labeling strategies

Ensures adequate communication with Therapeutics, CMC and International and Operations Regulatory functions

Ensures alignment of overall key labeling statements and key messages across labeling documents

Accountable for the timely preparation and content of core data sheets and labeling documents

Responsible for leading interactions with DDMAC for assigned products

Is accountable as required for escalating issues to upper management, evaluating regulatory risks and developing mitigations plans for promotional materials and labeling in close cooperation with regulatory senior management

Provides advice and counsel on labeling impact/requirements during discussions of labeling concepts during early stage product development. May propose draft labeling text during these discussions.

Communicates changes in regulations and practices to the organization effectively and quickly.

QUALIFICATIONS

Basic qualifications:
A minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful. Must have a minimum of 10 years experience in Regulatory Affairs Labeling or Promotional Review or equivalent experience within the pharmaceutical industry.

Preferred qualifications:
Previous experience in participating in early stage development discussions including Target Product Profile and determination of relevant clinical endpoints to inform the proposed product label is also preferred.

Demonstrate a solid working knowledge of drug development process and knowledge of FDA labeling and promotional requirements; EU, Canada, and ROW experience highly desirable. Candidates must be able demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).