tarsusrx

tarsusrx

Sr Director, Regulatory Affairs Strategy

Irvine, California, United States · Director

Sponsorship not specified$227k-$317kDetected 1 day ago
Project ManagementBusiness DevelopmentNegotiationFDA 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

  • The individual should be able to proactively anticipate and mitigate regulatory risk, ensure compliance with global regulatory requirements and develop development acceleration strategies.
  • 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.

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

  • 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.

Equal opportunity

  • Equal Opportunity Employer.
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