Travere Therapeutics
Senior Director, Regulatory Affairs CMC
Travere Therapeutics, Boston, Massachusetts, us, 02298
Department:
107000 RegulatoryLocation:
San Diego, USA- RemoteBe 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.Position Summary:The Senior Director, Regulatory Affairs CMC will be responsible for the global management and leadership of regulatory activities relating to global chemistry, manufacturing and controls (CMC/Quality) regulatory affairs function. This role is responsible for defining and executing global regulatory affairs CMC strategies pertaining to the development, registration and regulatory compliance of Travere Therapeutics, Inc. products in the United States, European Union, Asia Pacific and Latin America. This includes interacting with the FDA, EMA and national Regulatory Agencies in the EU Member States and other health authorities as needed to ensure timely submission, approval and maintenance of company products.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.Design 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 with 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.Education/Experience Requirements:Bachelor's Degree in a scientific and/or Life Sciences discipline. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.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.Additional Skills/Experience: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.Total Rewards Offerings:Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.Benefits:
Our benefits include 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 and generous paid time off.Compensation:
Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.Target Base Pay Range:$215,000.00 - $280,000.00*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.Travere will accept applications on an ongoing basis until a candidate is selected for the position.If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to
accommodations@travere.com . Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
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107000 RegulatoryLocation:
San Diego, USA- RemoteBe 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.Position Summary:The Senior Director, Regulatory Affairs CMC will be responsible for the global management and leadership of regulatory activities relating to global chemistry, manufacturing and controls (CMC/Quality) regulatory affairs function. This role is responsible for defining and executing global regulatory affairs CMC strategies pertaining to the development, registration and regulatory compliance of Travere Therapeutics, Inc. products in the United States, European Union, Asia Pacific and Latin America. This includes interacting with the FDA, EMA and national Regulatory Agencies in the EU Member States and other health authorities as needed to ensure timely submission, approval and maintenance of company products.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.Design 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 with 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.Education/Experience Requirements:Bachelor's Degree in a scientific and/or Life Sciences discipline. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.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.Additional Skills/Experience: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.Total Rewards Offerings:Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.Benefits:
Our benefits include 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 and generous paid time off.Compensation:
Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.Target Base Pay Range:$215,000.00 - $280,000.00*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.Travere will accept applications on an ongoing basis until a candidate is selected for the position.If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to
accommodations@travere.com . Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
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