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Director Regulatory Strategy Jobs (NOW HIRING)

Travere

Director, Regulatory Affairs Strategy

San Diego, CA · On-site +1

$159K - $210K/yr

The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support successful clinical ...

Travere

Director, Regulatory Affairs Strategy

$153K - $202K/yr

The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support successful clinical ...

Orchard Therapeutics plc.

$190 - $240/hr

Develop the US regulatory strategy under the oversight of the Executive Director, Regulatory Science, including any innovative procedures to expedite the path to approval, in line with corporate ...

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Director Regulatory Strategy information

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$91K

$176.2K

$248.5K

How much do director regulatory strategy jobs pay per year?

As of Aug 30, 2026, the average yearly pay for director regulatory strategy in the United States is $176,150.00, according to ZipRecruiter salary data. Most workers in this role earn between $150,000.00 and $198,000.00 per year, depending on experience, location, and employer.

What does a director regulatory strategy do?

A Director of Regulatory Strategy is responsible for developing and implementing strategies to ensure a company's products or services comply with relevant regulations and standards. They monitor regulatory changes, advise leadership on potential impacts, and coordinate with internal teams to prepare documentation for regulatory submissions. This role often involves interacting with regulatory agencies, providing guidance during product development, and helping shape company policies to align with current and upcoming regulations. Their work is crucial in industries such as pharmaceuticals, biotechnology, medical devices, and financial services.

What are the key skills and qualifications needed to thrive as a director regulatory strategy?

To thrive as a Director Regulatory Strategy, you generally need an advanced degree in life sciences, pharmacy, or a related field, along with significant experience in regulatory affairs and strategy development. Familiarity with regulatory submission systems, global regulatory frameworks (such as FDA, EMA, ICH), and relevant certifications like RAC are highly valuable. Strong leadership, strategic thinking, and persuasive communication skills set top performers apart in this role. These competencies are critical for navigating complex regulatory landscapes, driving successful product approvals, and aligning organizational objectives with compliance requirements.

What are some common challenges a director regulatory strategy may face when managing cross-functional teams during product development?

A Director of Regulatory Strategy often encounters challenges such as aligning diverse stakeholder priorities, ensuring compliance with evolving regulations, and communicating regulatory requirements effectively across departments. They must bridge gaps between R&D, clinical, legal, and commercial teams to develop cohesive strategies that accelerate product approvals while mitigating risks. Strong project management, negotiation, and communication skills are essential to overcome these obstacles and drive successful outcomes.

What is the difference between Director Regulatory Strategy vs Regulatory Affairs Manager?

AspectDirector Regulatory StrategyRegulatory Affairs Manager
CredentialsTypically requires advanced degrees (e.g., MS, PhD) and extensive industry experienceRequires relevant degrees and certifications, such as RAC or RA certifications
Work EnvironmentStrategic planning, cross-department collaboration, executive-level interactionsOperational tasks, regulatory submissions, compliance management
Employer & Industry UsageUsed in pharmaceutical, biotech, and medical device companies for high-level strategyCommonly found in similar industries for managing regulatory processes

The main difference is that the Director Regulatory Strategy focuses on high-level strategic planning and policy development, while the Regulatory Affairs Manager handles day-to-day regulatory operations and submissions. Both roles require relevant credentials and industry experience, but the director position involves broader strategic responsibilities and leadership.

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Director Regulatory Strategy jobs near you
Infographic showing various Director Regulatory Strategy job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 86% Full Time, 9% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $176,150 per year, or $84.7 per hour.

Director Regulatory Affairs Strategy

Lynkx Staffing LLC

Princeton, NJ • On-site

$158K - $209K/yr

Full-time

Re-posted 19 days ago

Job description

Our Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants.
  • Lead/support Regulatory Affairs Functional Teams (RAFTs) to ensure the highest quality strategic regulatory input is provided to optimize regulatory outcomes and maximize product value.
  • Lead developing and creating global / regional regulatory strategies for multiple clinical development projects at all stages (Phase 1 through market authorization).
  • Author and / or review regulatory documents for submission to US and/or Rest of World regulatory agencies in support of formal meetings with health authorities and major applications (INDs / CTAs, NDAs / BLAs, MAAs, orphan, etc.)
  • Provide leadership and strategic input to the Filing Submission Team and lead other project sub-teams, as assigned.
  • Lead the preparation for and conduct of formal meetings with regulatory health authorities including the review of applications and negotiations with Health Authorities.
  • Provide on project teams or management committees regulatory expertise/advice on requirements for pre-clinical, clinical disciplines, as well as companion diagnostics, in support of drug candidates under development.
  • Create and maintain Regulatory Strategic Development plans and provide strategic input to global project development plans.
  • Identify and escalate potential Regulatory issues to executive management and propose risk evaluations and mitigation strategies.
  • Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations as needed.
  • Research regulatory requirements to support submissions or inquires from functional groups.
  • Remain current on changes in regulatory requirements and environment and be a resource to function groups for regulatory information.
  • Prepare and reviews SOPs / WIs to achieve consistency in regulatory standards and compliance.
  • Assure that all aspects of the Company’s regulatory activities are conducted in full compliance with application regulations and at the highest level of ethical standards.
REQUIREMENTS
  • Ph.D. or PharmD degree
  • 5-10 years Regulatory Affairs experience
  • Strong experience in Regulatory Strategy
  • Must have led or currently leading an NDA or BLA filing
  • Must have led or currently leading the strategy and authoring of a study plan, i.e., pediatric study, etc.
  • Must have led or currently leading label negotiations
  • Must have led the preparation of Briefing Documents for milestone meetings