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Sr Director, Regulatory Affairs Strategy
Irvine, California, United States · Director
Sponsorship not specified$227k-$317kDetected 1 day ago
Project ManagementBusiness DevelopmentNegotiationRecruitingHRFDA RegulatoryLeadershipCommunicationCollaborationCritical ThinkingRegulatory Affairs
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odds of building a lasting career here
37Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
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About the role
- The Senior Director Regulatory Affairs Strategy will play a key role in guiding assigned projects throughout development and lifecycle management by providing regulatory thought leadership and leveraging their extensive development experience.
- The individual will provide strategic as well as tactical regulatory leadership across all phases of product development, filing, and lifecycle management, to assure timely approval and compliant post-market performance in the US and key international markets.
- The role will require strong leadership and interpersonal skills, both written and verbal.
Responsibilities
- Serve as leader internally by collaborating across organizational levels and functions and effectively engaging stakeholders and influencing cross-functional decision-making to drive regulatory success.
- Develop and lead regulatory intelligence gathering as well as regulatory influence management at the portfolio level.
- The individual should be able to proactively anticipate and mitigate regulatory risk, ensure compliance with global regulatory requirements and develop development acceleration strategies.
- Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
Requirements
- In-depth understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices is required.
- The candidate must have at least 15 years of regulatory affairs experience in the US and ex-US environments and a higher degree (MD, PhD or PharmD) in a scientific discipline.
- The candidate must have at least 15 years of regulatory affairs experience and a higher degree (MD, Ph.D. or Pharm D.) in a scientific discipline.
- Ability to function at a high level in a team setting or acting as an individual contributor.
- Ability to thrive in a fast-paced, entrepreneurial environment.
- A high attention to detail and ability to coordinate and prioritize assigned projects.
Skills
- Your Human Resources Team
- Excellent verbal and written communication skills.
Compensation
- The expected base pay range for this position is $226,500- $317,100 plus bonus, stock equity, and comprehensive benefits.
Benefits
- Represent regulatory affairs in governance and in interactions with global health authorities, as applicable, to enable efficient pathways for development through lifecycle management
Company info
- We provide a hybrid work environment; remote work may be considered. - We are passionate about our culture!
- At Tarsus, we understand the importance of attracting and retaining top talent.
- Follow company policies and procedures for regulatory record keeping and lead development of new regulatory policies and procedures.
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