Regulatory Affairs Director

4 weeks ago

Salt Lake, Utah, United States Retrophin Full time

Job Summary:

The Executive Director, Regulatory Affairs will lead the development and execution of global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease, ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.

This key member of the Regulatory team will provide strategic and operational regulatory direction and mentorship on projects, including the use of regulatory tools in developing accelerated global regulatory approval strategies using novel endpoints, biomarkers or alternative clinical trial data and critical issue management based on current registration requirements and applicable industry standards.

The successful candidate will develop and execute fast to market regulatory strategies, regulatory requirements for clinical studies, marketing approval, evidence generation and life cycle management, managing interface with outside regulatory agencies and trade associations and acting as an advisor/liaison to senior management in order to plan, evaluate and recommend global regulatory strategy.

Responsibilities include the preparation, submission and maintenance for product specific dossiers (IND/CTA, NDA/MAA and others as required) per local country requirements with relevant health authorities, ensuring the accurate maintenance of archives and databases as required, negotiating with regulatory authorities and responding to regulatory authority queries during the development and review process to ensure submission approval.

The Executive Director, Regulatory Affairs will also ensure annual licenses, registrations, listings and patent information are maintained, ensuring compliance with product post marketing approval requirements, labeling, publications, advertising and promotional items are compliant with regulatory requirements, assessing regulatory impacts associated with changes made in the development of products and collaborating with internal stakeholders (Medical, Clinical, preclinical) and project leadership team to define or develop and obtain registration documents as required to support global development actions.

Key Responsibilities:

  • Develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease
  • Provide strategic and operational regulatory direction and mentorship on projects
  • Develop and execute fast to market regulatory strategies, regulatory requirements for clinical studies, marketing approval, evidence generation and life cycle management
  • Manage interface with outside regulatory agencies and trade associations
  • Act as an advisor/liaison to senior management in order to plan, evaluate and recommend global regulatory strategy
  • Prepare, submit and maintain product specific dossiers (IND/CTA, NDA/MAA and others as required) per local country requirements with relevant health authorities
  • Negotiate with regulatory authorities and respond to regulatory authority queries during the development and review process to ensure submission approval
  • Ensure annual licenses, registrations, listings and patent information are maintained
  • Ensure compliance with product post marketing approval requirements, labeling, publications, advertising and promotional items are compliant with regulatory requirements
  • Assess regulatory impacts associated with changes made in the development of products
  • Collaborate with internal stakeholders (Medical, Clinical, preclinical) and project leadership team to define or develop and obtain registration documents as required to support global development actions

Requirements:

The successful candidate will have a strong background in regulatory affairs, with experience in developing and executing global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease, ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.

They will have excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams, including Medical, Clinical, preclinical and project leadership teams.

The ideal candidate will have a strong understanding of regulatory requirements and standards, with experience in managing interface with outside regulatory agencies and trade associations and acting as an advisor/liaison to senior management in order to plan, evaluate and recommend global regulatory strategy.

They will also have strong analytical and problem-solving skills, with the ability to assess regulatory impacts associated with changes made in the development of products and develop and execute fast to market regulatory strategies, regulatory requirements for clinical studies, marketing approval, evidence generation and life cycle management.

What We Offer:

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer, offering a competitive salary and benefits package, including medical, dental and vision insurance, 401(k) plan, paid time off and holidays, and opportunities for professional growth and development.

We are committed to creating a diverse and inclusive work environment that values and respects the contributions of all employees, and we are proud to be an equal opportunity employer.

How to Apply:

If you are a motivated and experienced regulatory professional looking for a new challenge, please submit your resume and cover letter to [insert contact information].

We look forward to hearing from you

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