Regulatory Affairs Director jobs in Orange, CA

About the Role

The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products, with a focus on US regulatory affairs both pre- and post-approval. The individual will function as the regulatory lead for the assigned projects. Experience in development and clinical regulatory activities and providing regulatory leadership on the project teams in this area is required. The candidate will also directly provide or oversee pre- and post-approval submissions activities.

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

• Provide regulatory leadership on the project teams, with a focus on development and clinical regulatory affairs, but with good knowledge of other areas of regulatory affairs.
• Work with project teams to resolve complex project issues utilizing regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements.
• Work in close collaboration with other functional leads to plan, prioritize, supervise and/or conduct project activities.
• Provide interpretation of regulatory authorities’ feedback, policies and guidelines.
• Develop regulatory strategic plans, either directly or in conjunction with project teams.
• Lead or oversee the preparation of regulatory submissions for assigned projects; responsible for quality and timeliness of IND/CTA/NDA/MAA and post-approval submissions.
• Work with cross-functional partners and contractors in the preparation, review, and completion of documents for regulatory submissions.

Factors for Success:

• Advanced degree (MD, PhD or PharmD)
• Minimum of 10 years of regulatory affairs experience
• Strong interpersonal skills, both written and verbal, are desired.
• Excellent verbal and written communication skills.
• Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills evidenced by past performance on drug development project teams.
• Ability to thrive in a fast-paced, entrepreneurial environment.
• Ability to function at a high level in a team setting or acting as an individual contributor.
• An excellent understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• A high attention to detail and ability to coordinate and prioritize assigned projects.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with a courtyard, table tennis, snacks and drinks, and occasional catered meals. We provide a hybrid work environment; remote work may be considered.
• 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 VP, Regulatory Affairs.
• Some travel may be required – up to 10%.
• The candidate must have at least 10 years of regulatory affairs experience and a higher degree (MD, Ph.D. or Pharm D.).

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $181,200 - $235,600 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://alliantbenefits.cld.bz/Tarsus2023BenSnapshot. 

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