Travere Therapeutics
Senior Director, Commercial Regulatory Affairs
Travere Therapeutics, Oklahoma City, Oklahoma, United States, 73116
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 Senior Director, Commercial Regulatory Affairs is responsible for overseeing review of promotional and medical communication materials across the product portfolio. In this role, the Senior Director will represent Regulatory Affairs at Promotional Review Committee and Medical Review Committee meetings and other commercial review teams. The Senior Director is responsible for development of global core data sheet and initial package insert/summary of medicinal product characteristics. Key accountabilities include providing promotional regulatory guidance and strategy to key internal stakeholders to advance the commercialization of novel compounds and life cycle development of assigned products and assuring compliance with global regulatory standards and commitments. Responsibilities: Liaison responsibility on behalf of Regulatory Affairs for FDA advertising and promotion (Ad/Promo) issues and providing internal training as needed on FDA requirements. Provide global regulatory Ad/Promo insight and regulatory procedural expertise in line with applicable regulatory guidelines. Ensure accurate and timely compilation and submission of Ad/Promo documentation. Represent Regulatory Affairs at PRC team meetings including other assigned teams i.e. sub-teams, labeling and promotional reviews. Apply influence and negotiation skills to support development results and resolve issues. Direct and ensure effective execution of optimal strategies for labeling development. Ensure global regulatory compliance standards and commitments are met. Liaise with FDA/OPDP as needed for product portfolio. Establish global strategic consistency across regional regulatory submissions by contributing to and reviewing regional-specific technical strategic regulatory documentation. Effectively monitor and ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines. Develop SOPs and working instructions to ensure high performing commercial regulatory operations and effective review processes. Collaborate with key internal partners and other key stakeholders to support a globally effective organization. Hire and develop team members within commercial regulatory. Education/Experience Requirements: Bachelor's Degree in Life Science or other related discipline. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered. Minimum of 12 years' regulatory experience in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 7 years' experience in a regulatory leadership role. Demonstrated track record of successful approval and launches is required. Prior regulatory agency liaison experience is essential. Strong expertise and knowledge of the Ad/Promo regulations is required. Experience in drug safety, pharmacovigilance and/or risk management preferred. Strong understanding of US laws and procedures relating to drug market authorizations, European Union a plus. Additional Skills/Experience: The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork. Strong professional experience in a similar role within the pharmaceutical industry, preferably small molecule pharmaceuticals. 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 complexity. Strong interpersonal and organizational skills and excellent verbal and written communication skills are required. Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes. Strong ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions. Strong influencing and negotiation skills. Successful record of creating and managing complex project plans, timelines, budgets, and critical paths. Ability to function effectively in a global scientific and cultural arena. Excellent team management skills, ability to lead, train and mentor team members at all levels. Work independently under general supervision. Exercises judgment within defined practices and policies. Ensure effective liaison with regulatory affairs counterparts to ensure aligned representation and decision making at assigned teams. Ability to travel 10-20% domestic and internationally. 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 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 Senior Director, Commercial Regulatory Affairs is responsible for overseeing review of promotional and medical communication materials across the product portfolio. In this role, the Senior Director will represent Regulatory Affairs at Promotional Review Committee and Medical Review Committee meetings and other commercial review teams. The Senior Director is responsible for development of global core data sheet and initial package insert/summary of medicinal product characteristics. Key accountabilities include providing promotional regulatory guidance and strategy to key internal stakeholders to advance the commercialization of novel compounds and life cycle development of assigned products and assuring compliance with global regulatory standards and commitments. Responsibilities: Liaison responsibility on behalf of Regulatory Affairs for FDA advertising and promotion (Ad/Promo) issues and providing internal training as needed on FDA requirements. Provide global regulatory Ad/Promo insight and regulatory procedural expertise in line with applicable regulatory guidelines. Ensure accurate and timely compilation and submission of Ad/Promo documentation. Represent Regulatory Affairs at PRC team meetings including other assigned teams i.e. sub-teams, labeling and promotional reviews. Apply influence and negotiation skills to support development results and resolve issues. Direct and ensure effective execution of optimal strategies for labeling development. Ensure global regulatory compliance standards and commitments are met. Liaise with FDA/OPDP as needed for product portfolio. Establish global strategic consistency across regional regulatory submissions by contributing to and reviewing regional-specific technical strategic regulatory documentation. Effectively monitor and ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines. Develop SOPs and working instructions to ensure high performing commercial regulatory operations and effective review processes. Collaborate with key internal partners and other key stakeholders to support a globally effective organization. Hire and develop team members within commercial regulatory. Education/Experience Requirements: Bachelor's Degree in Life Science or other related discipline. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered. Minimum of 12 years' regulatory experience in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 7 years' experience in a regulatory leadership role. Demonstrated track record of successful approval and launches is required. Prior regulatory agency liaison experience is essential. Strong expertise and knowledge of the Ad/Promo regulations is required. Experience in drug safety, pharmacovigilance and/or risk management preferred. Strong understanding of US laws and procedures relating to drug market authorizations, European Union a plus. Additional Skills/Experience: The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork. Strong professional experience in a similar role within the pharmaceutical industry, preferably small molecule pharmaceuticals. 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 complexity. Strong interpersonal and organizational skills and excellent verbal and written communication skills are required. Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes. Strong ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions. Strong influencing and negotiation skills. Successful record of creating and managing complex project plans, timelines, budgets, and critical paths. Ability to function effectively in a global scientific and cultural arena. Excellent team management skills, ability to lead, train and mentor team members at all levels. Work independently under general supervision. Exercises judgment within defined practices and policies. Ensure effective liaison with regulatory affairs counterparts to ensure aligned representation and decision making at assigned teams. Ability to travel 10-20% domestic and internationally. 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.
#J-18808-Ljbffr