Legal Jobs in Irvine, CA (Now Hiring) — 67 open — Page 4

 

About the Role

The Manager II, Regulatory Affairs will report to the Sr. Director, Regulatory Affairs, and will manage the labeling, advertising, and promotional review and activities associated with it for Tarsus.

Let’s talk about some of the key responsibilities of the role:

• Assist in performing and managing the initial part of the workflow (Initial QC, routing, scheduling meetings, etc.) in the Veeva system for material review and approval of the materials submitted from the assigned business units
• Review/approve promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices
• Manage and help develop a regulatory labeling, advertising, and promotion function, including processes and systems.
• Represent regulatory on the Medical, Legal, and Regulatory review committee. Represent the promotional regulatory perspective with cross-functional partners from Commercial, Medical Affairs, and Business Conduct (US Legal).
• Serve as the Regulatory point of contact for the regulatory promotional perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings, as needed.
• Review and interpret enforcement letters, keep current with industry changes relating to advertising and promotion, and interpret new guidance to the Industry.
• Track all 2253 submissions and health authority activity to aid in resource planning for R&D submissions.
• Manage and draft responses to Health Authorities' queries. Provide support at labeling-related negotiation meetings or teleconferences.

Factors for Success:

• Bachelor’s Degree in science or health-related discipline required.
• 8+ years of relevant experience, with a minimum of 5 years as a regulatory affairs reviewer on MLR/PRC committee . Broad knowledge of the pharmaceutical industry is preferred.
• Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency.
• Strong interpersonal skills with the ability to influence others in a positive and effective manner.
• Ability to work in a team environment.
• Demonstrated ability to contribute to a continuous learning and process improvement environment.
• Under the guidance of the Sr. Director, knowledgeable resource for regulatory advice on promotional, corporate, and other non-promotional initiatives in other departments
• Experience working with Veeva PromoMats Vault is a plus.
• Experience in interpreting regulations, guidelines, and policy statements, including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to labelling.
• Tarsus Competencies:
  • Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there’s not a blueprint for success. Owns their decisions and actions.
  • Collaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.
  • Outcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met.

A Few Other Details Worth Mentioning:

• The position can be either Remote or based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our Sr. Director, Regulatory Affairs
• Travel may be required – up to 10%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $120,000 - $168,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

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