itcss
Manager II, Regulatory Affairs
Irvine, California, United States · Mid
Sponsorship not specified$120k-$168kDetected 53 days ago
NegotiationProcess ImprovementRecruitingHRFDA RegulatoryCollaborationRegulatory Affairs
About the role
- The Manager II, Regulatory Affairs will report to the Sr.
- 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
- Represent regulatory on the Medical, Legal, and Regulatory review committee.
Responsibilities
- Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner.
- 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.
- Director, Regulatory Affairs, and will manage the labeling, advertising, and promotional review and activities associated with it for Tarsus.
- Manage and help develop a regulatory labeling, advertising, and promotion function, including processes and systems.
- Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency.
Requirements
- Strong interpersonal skills with the ability to influence others in a positive and effective manner.
- Ability to work in a team environment.
- Experience in interpreting regulations, guidelines, and policy statements, including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to labelling.
- Travel may be required - up to 10%
Nice to have
- 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.
- Experience working with Veeva PromoMats Vault is a plus.
Skills
- Your Human Resources Team
Compensation
- The expected base pay range for this position is $120,000 - $168,000 plus bonus, stock equity, and comprehensive benefits.
Benefits
- Bachelor's Degree in science or health-related discipline required.
- Demonstrated ability to contribute to a continuous learning and process improvement environment.
- The position can be either Remote or based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals.
Company info
- We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
- 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 listing is sourced directly from itcss's careers page and normalized into a canonical job model.