Senior Manager, Commercial Regulatory

Travere Therapeutics; Boston (MA); Remote; USD 128,000 - 165,000; Full time

Job summary

Join a forward-thinking biopharmaceutical company dedicated to transforming the lives of patients with rare diseases. As a Senior Manager in Commercial Regulatory, you will play a pivotal role in ensuring compliance with regulatory standards while collaborating with cross-functional teams. This position offers the opportunity to impact the development of life-changing therapies, all within a dynamic and supportive work environment. With a strong emphasis on teamwork and patient focus, you'll thrive in a culture that values courage and community spirit. If you are passionate about making a difference and possess the necessary expertise, this role is perfect for you.

Benefits

Premium health insurance

Life insurance

Disability benefits

Retirement plans with employer match

Generous paid time off

Wellness programs

Employee support programs

Qualifications

• 7+ years of regulatory experience in the Biotech or Pharmaceutical industry.
• Knowledge of US labeling requirements and regulations.

Responsibilities

• Assist with labeling development and regulatory advertising.
• Review and approve US promotional materials for assigned assets.

Skills

Regulatory Affairs

Labeling Development

Promotional Materials Review

Analytical Skills

Interpersonal Skills

Project Management

Education

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

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 Senior Manager, Commercial Regulatory is responsible for assisting with 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:

* Assist cross-functional teams in development of target product profile, core data sheet, and regional labels.
* Review and approval of 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 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.
* Assist in Regulatory Intelligence in 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 7+ 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:

* 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. Ability to perform job duties with minimal oversight.
* 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.
* Ability to adapt to evolving project timelines and goals, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.

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:

$128,000.00 - $165,000.00

*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.

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

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [e-mail]. 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.