Sr Director, Regulatory Affairs Strategy

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 individual should be able to proactively anticipate and mitigate regulatory risk, ensure compliance with global regulatory requirements and develop development acceleration strategies. In-depth understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices is required. The role will require strong leadership and interpersonal skills, both written and verbal. The candidate must have at least 15 years of regulatory affairs experience in the US and ex-US environments and a higher degree (MS, Ph.D. or PharmD) in a scientific discipline.

Key responsibilities of the role

• 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.

• Oversee the development and execution of cutting-edge early-development through post-approval global regulatory strategies for complex assets and indications in partnership with other regulatory strategists and cross-functional stakeholders

• Provide regulatory leadership in global regulatory teams and product teams, including development regulatory strategy, planning, preparation and execution of major regulatory submissions (US and global), global submission rollout and lifecycle management strategies for marketed products including post-approval changes, ensuring continuous compliance

• Represent regulatory affairs in governance and in interactions with global health authorities, as applicable, to enable efficient pathways for development through lifecycle management

• Accountable for all US regulatory submissions and approvals for assigned projects.

• Able to identify and communicate regulatory hurdles, risks, opportunities, and innovative pathways to accelerate development and approval.

• Develop and lead regulatory intelligence gathering as well as regulatory influence management at the portfolio level.

• Provide strategic leadership and development to other regulatory strategists to ensure innovative, robust, fit-for-phase regulatory strategies for from FIH to approval.

• Provide regulatory strategy leadership for business development and due diligence, including assessment of asset, risk identification and mitigation, precedent leverage, regulatory probability of success

• Establish best practices across Regulatory Affairs and other R&D functions to ensure consistent, high-quality execution

• Follow company policies and procedures for regulatory record keeping and lead development of new regulatory policies and procedures.

• Advance the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects.

Factors for Success

• The candidate must have at least 15 years of regulatory affairs experience and a higher degree (MS, Ph.D. or Pharm D.) in a scientific discipline.

• 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 function at a high level in a team setting or acting as an individual contributor.

• Ability to thrive in a fast-paced, entrepreneurial environment.

• 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.

• Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.

• Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.

• 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.

• Business Acumen - Demonstrates strong business acumen by anticipating market dynamics and using financial and strategic insight to guide investments, manage risk, and align priorities with long-term organizational value.

• Innovative Mindset and Action - Demonstrates an innovative mindset by championing new ideas, investing in enabling systems and partnerships, and translating innovation into sustainable growth and organizational resilience.

A Few Other Details Worth Mentioning

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, 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 20%.

At the company, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $226,500- $317,100 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 the company benefits, please visit: [link for members] .

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The company, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.