Senior director, Regulatory affairs & Operations

 

Role Summary

The Senior Director, Regulatory Affairs & Operations will ensure that there is a sound regulatory foundation for the successful advancement of Tremeau’s pipeline of products so that they are well positioned for regulatory approval. This person will be responsible for co-developing, leading, and implementing short- and long-term regulatory strategies, regulatory interactions, and submissions throughout the product lifecycle. These responsibilities extend from R&D through post-marketing.

 Responsibilities

  • Works with the Head of Regulatory Affairs & Corporate Quality to define innovative and sound regulatory strategy to optimize product development for Tremeau’s portfolio of products

  • Provides regulatory guidance/strategy/perspective in team meetings and presentations

  • Implements product related regulatory strategies, processes and activities in accordance with national legislation and regulatory requirements

  • Directs the development of the product label by collaborating cross-functionally to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent

  • Authors, coordinates, reviews & critiques documents that will be included in regulatory submissions and interactions

  • Interacts with and manages internal/external functional business partners to gather data and develop documentation required for on-time regulatory submissions

  • Provides regulatory input and tactical support for development programs, including creating regulatory development plans for complete and accurate IND submissions; ensuring that clinical trials are designed to meet regulatory requirements; and guiding programs to successful NDAs in support of registration submissions

  • Serves as primary liaison with FDA, including providing support for and coordination of regulatory meetings and information package development

  • Leads initiatives to improve overall Regulatory Operations efficiency, quality, and output

  • Develops and implements Standard Operating Procedures and Regulatory Affairs processes as needed

  • Leads the Promotional Materials Review Committee (PMRC) Process, providing guidance to maintain compliance with FDA advertising and promotional regulations, pertinent laws and company policy

Requirements

  • 8+ years of progressively responsible experience in drug development and regulatory affairs in the pharmaceutical industry

  • Advanced degree (e.g., MSc, MD, MPH, PharmD or PhD) or equivalent education/degree in Chemistry, Biochemistry, or related pharmaceutical science

  • Comprehensive understanding of regulatory activities, touch points, and how they affect projects and processes

  • Strong oral and written communication skills

  • In-depth working knowledge and understanding of the drug development process, laws, regulations, and guidelines, with deep understanding of the FDA

  • Direct interactions/meetings/negotiations with FDA and/or other regulatory authorities

  • Able to successfully interpret and apply regulatory intelligence to work output

  • Able to establish close communications and working relationship with cross functional partners to meet business objectives

  • Able to present to senior leadership clearly, succinctly, with open-mindedness, and willingness to defend difficult positions

  • Experience with supporting early and late phase development projects, including filing of IND and NDAs submissions   

  • Prior experience of NDAs and gaining US regulatory approvals

  • Strong analytical skills and the ability to understand, balance, and articulate both tactical and strategic issues and solutions

  • Demonstrated ability to work independently with exceptional organization and attention to detail

  • Proficient in the delivery and conduct of all Regulatory Affairs activities including, but not limited to submissions, publishing, review, and oversight

If you would like to apply for this position, send your resume to careers@tremeaurx.com, noting the position in the subject line.