Associate Director, Commercial Regulatory Affairs
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Posted 19 days ago
Job Description

Department:

107000 Regulatory

Location:

San Diego, USA- Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

Position Summary:

The Associate Director, Commercial Regulatory Affairs is responsible for labeling development and Regulatory advertising and promotion. As a member of the Commercial Regulatory Team, this person works closely with internal stakeholders to ensure that labeling and advertising/promotional activities are aligned with both internal strategies and regulatory guidance. This position represents Regulatory Affairs on key review committees and assures compliance with all market commitments and global regulatory standards.

Responsibilities:

  • Lead cross-functional teams in development of target product profile, core data sheet, and regional labels.
  • Responsible for review and approval of all US promotional materials for assigned assets.
  • Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are consistent with regulatory guidelines and support business objectives.
  • Collaborate cross-functionally to achieve team, department, and corporate goals across programs.
  • Liaise effectively with Regulatory Affairs counterparts to ensure aligned representation and decision making.
  • Ensure effective and professional relationships with internal teams, external scientific and business partners, regulatory experts, and health authorities.
  • Ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines.
  • Research and analyze regulatory information and maintain current regulatory knowledge.
  • Identify gaps and challenges and propose options to address them.
  • Apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.

Education/Experience Requirements:

  • Bachelor's degree in related Life Sciences discipline. Master's degree preferred. Equivalent combination of education and applicable job experience may be considered.
  • Minimum 8 years of regulatory and/or related experience (e.g., labeling, ad promo, drug development, medical writing, etc.) within the Biotech or Pharmaceutical industry.
  • Knowledge and understanding of pharmaceutical drug development and regulations pertaining to labeling, specifically, US labeling requirements and guidance.
  • Demonstrated ability to understand implications of label changes on pending and approved labels.

Additional Skills/Experience/Requirements:

  • The ideal candidate will embody Travere's core values: courage, community spirit, patient focus, and teamwork.
  • This position requires academic scientific training, analytical skills, and keen attention to detail.
  • Strong professional experience in a similar role within the pharmaceutical industry.
  • Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
  • Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complex projects and interdependent timelines.
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
  • Successful record of creating and managing complex project plans, timelines, budgets, and critical paths.
  • Ability to adapt to evolving project timelines and goals, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
  • Ability to travel 10% domestic and internationally.
  • Travere will require proof of vaccination status to perform onsite, face to face work or to become employed.

COVID-19 VACCINATION REQUIREMENT

Where permitted, the Company requires all employees to be fully vaccinated against COVID-19 as a conditionof employment unless an exemption or accommodation is available and approved. Being fully vaccinated means that an individual is at least two weeks past their final dose of an authorized COVID-19 vaccine regimenand may include the individual obtaining vaccination boosters at certain intervals. Where permitted, as a condition of employment, final candidates will be required to provide proof of their COVID-19 vaccination unless an exemption or accommodation is available and approved. View the candidate COVID-19 vaccination policy webpage for information about the exemption or accommodation process for final candidates.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
8+ years
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