Be an early applicantLess than 25 applicants

Company

Travere Therapeutics · 6 hours ago

Senior Director, Regulatory Affairs CMC

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$215K/yr - $280K/yr

12+ years exp

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BiotechnologyHealth Care

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Define and execute the global CMC/quality regulatory strategy for Travere Therapeutics, Inc. products including maintaining and extending product registrations in United States, European Union, Asia Pacific and Latin America markets.

Designs global CMC/quality regulatory strategies in close collaboration with GRL to obtain, maintain and extend product registrations in US, Europe and ROW.

Provide regional global CMC/quality regulatory expertise and work in collaboration with the GRL in organizing and providing support to meetings Health Authorities.

Provide global regulatory strategic insight and regulatory procedural expertise in line with applicable directives and regulatory guidelines.

Partner with global CMC/Quality regulatory stakeholders on strategies for Travere Therapeutics, Inc. investigational and licensed products in all applicable regions, including but not limited to United States, European Union, Asia Pacific and Latin America.

Collaborate closely with internal regulatory stakeholders (Strategy/Development, CMC, Labeling, and Operations) and regulatory staff at vendor and partner companies to ensure that all aspects of regulatory strategies are coordinated and considered.

Assure accurate and timely compilation and submission of regulatory documentation.

Lead the Travere Therapeutics, Inc. Global CMC/Quality Regulatory function by providing direction, guidance, and mentorship to direct reports.

Represent Travere Therapeutics, Inc. Regulatory Affairs in Travere Therapeutics, Inc. global CMC/quality matters and operations.

Direct and lead cross-functional submission teams to ensure creation and submission of global CMC/quality regulatory documents (NDA, MAA, Briefing documents, Variations, ODD, PIP, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives.

Partner with functional stakeholders to ensure the timely submission, approval and compliance of global CMC/quality information for all IND/CTA applications conducted in the United States, European, Asia Pacific and Latin America region, as applicable.

Establish and maintain strong working relationships with appropriate contacts at relevant regulatory agencies, especially the FDA, European Medicines Agency and regulatory agencies in the EU member states to ensure regulatory applications are approved in a timely manner.

Remain knowledgeable about current regulations and guidance, interpret and notify appropriate personnel of any changes, updates or revisions.

Communicate and collaborate with the partner organizations to ensure all parties are informed of activities directly affecting their market.

As the global CMC/quality regulatory expert, ensure any necessary knowledge is transferred throughout the Regulatory team and internal stakeholders.

Ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, to adhere to compliance with appropriate regulations, guidelines and post market commitments.

Support new Business Development initiatives including due diligence and regulatory technical assessments as needed.

Qualification

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Regulatory AffairsCMC StrategiesDrug Development ProcessGlobal SubmissionsRegulatory ComplianceFDA LiaisonLeadership ExperienceTeam Management

Required

Bachelor’s Degree in a scientific and/or Life Sciences discipline.

Minimum of 12 years in drug/biologics development in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 7 years of experience in a regulatory leadership role.

Demonstrated track record of successful approvals and extensive regulatory agency liaison experience is essential.

Strong expertise and knowledge of the drug development process, Global submissions (eg NDA/MAA/NDS) and launch requirements is required.

Strong understanding of US and European Union laws and procedures relating to drug market authorizations.

Leadership experience managing a team of Regulatory CMC professionals.

Preferred

Advanced degree preferred.

Strong ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.

Excellent interpersonal, communication, analytical and organizational skills.

Strong influencing and negotiation skills.

Capable of managing multiple projects and complex timelines in a team environment.

Demonstrate leadership capacity in a highly matrix working environment by interacting effectively with internal departments and external organizations.

Excellent team management skills, ability to lead, train and mentor team members at all levels.

Communicate with Sr. Level Governance committees to ensure awareness of global regulatory CMC activities and needs.

Ensure effective liaison with regulatory affairs counterparts to guarantee aligned representation and decision making at assigned teams.

May require some domestic and international travel.

Benefits

Premium health

Financial

Work-life and well-being offerings for eligible employees and dependents

Wellness and employee support programs

Life insurance

Disability

Retirement plans with employer match

Generous paid time off

Company

Travere Therapeutics

Travere discovers and develops drugs for the treatment of catastrophic diseases that are debilitating and often life-threatening.

Founded in 2008

San Diego, California, USA

201-500 employees

https://travere.com/

H1B Sponsorship

Travere Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (3)

2020 (1)