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Regulatory Strategy Jobs in Raleigh, NC (NOW HIRING)

UCB

GRA Device Lead, Raleigh, NC

Raleigh, NC · Hybrid

$148K - $195K/yr

About the role The Global Regulatory Affairs Devices Lead supports regulatory strategy and submissions for marketed and development medical devices and combination products within Neurology ...

UCB

GRA Device Lead, Raleigh, NC

Raleigh, NC · On-site

$148K - $195K/yr

About the role The Global Regulatory Affairs Devices Lead supports regulatory strategy and submissions for marketed and development medical devices and combination products within Neurology ...

Bioventus LLC

Regulatory Affairs Manager

Durham, NC · On-site

$90 - $120/hr

The Regulatory Affairs Manager is responsible for developing and executing global regulatory strategies to plan, prepare, and obtain approvals and maintain compliance with national and international ...

JobRx, Inc.

Director, Regulatory Affairs

Durham, NC · On-site

$130 - $160/hr

The Director, Regulatory Affairs will execute developed strategies for earliest possible approvals of the company's regulatory applications at all stages of product development and post approval ...

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

The Director, Regulatory Affairs will execute developed strategies for earliest possible approvals of the company's regulatory applications at all stages of product development and post approval ...

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Regulatory Strategy information

See Raleigh, NC salary details

$39.4K

$92.7K

$134.6K

How much do regulatory strategy jobs pay per year?

As of Aug 9, 2026, the average yearly pay for regulatory strategy in Raleigh, NC is $92,747.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,400.00 and $108,900.00 per year, depending on experience, location, and employer.

What is regulatory strategy?

Regulatory strategy refers to the planning and management of processes to ensure that a company's products or services comply with applicable laws, regulations, and industry standards. This often involves working with regulatory agencies, preparing and submitting documentation, and staying updated on regulatory changes that could impact the business. Professionals in regulatory strategy play a critical role in guiding companies through approval processes, minimizing compliance risks, and ensuring timely entry into markets. Their expertise helps organizations navigate complex regulatory landscapes efficiently and effectively.

What are the key skills and qualifications needed to thrive in regulatory strategy?

Success in Regulatory Strategy requires a strong understanding of regulatory frameworks, compliance processes, and strategic planning, often supported by a degree in life sciences, law, or a related field. Familiarity with regulatory submission systems, databases, and certifications like RAC (Regulatory Affairs Certification) is common. Excellent analytical thinking, communication, and negotiation skills set outstanding professionals apart in this field. These competencies are crucial for ensuring that products meet regulatory requirements efficiently, enabling timely market access and reducing compliance risks.

What are some common challenges faced in a regulatory strategy role, and how can they be addressed?

Professionals in Regulatory Strategy often navigate complex and evolving regulatory environments, which can make it challenging to keep up with changing requirements across multiple regions. Balancing business goals with regulatory compliance sometimes requires creative problem-solving and effective stakeholder communication. To address these challenges, it's important to stay informed through continual training, foster strong relationships with regulatory authorities, and collaborate closely with cross-functional teams such as R&D, legal, and quality assurance. This proactive approach helps ensure that strategic objectives are met while maintaining compliance.

What is the difference between Regulatory Strategy vs Regulatory Affairs?

AspectRegulatory StrategyRegulatory Affairs
Primary FocusDeveloping long-term plans to meet regulatory requirements and facilitate product approvalManaging day-to-day regulatory submissions, compliance, and communication with authorities
Work EnvironmentStrategic planning, cross-functional collaboration, market entry planningDocumentation, submission management, regulatory compliance activities
Required CredentialsTypically advanced degrees in life sciences, regulatory affairs certificationsSimilar credentials, often with regulatory affairs certifications

Regulatory Strategy focuses on planning and aligning regulatory pathways for product approval, while Regulatory Affairs handles the execution of these plans through submissions and compliance activities. Both roles require similar qualifications but differ in scope and daily responsibilities.

What are popular job titles related to Regulatory Strategy jobs in Raleigh, NC? For Regulatory Strategy jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Regulatory Strategy jobs in Raleigh, NC look for? The top searched job categories for Regulatory Strategy jobs in Raleigh, NC are:
Regulatory Strategy jobs near you
Infographic showing various Regulatory Strategy job openings in Raleigh, NC as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 9% Part Time, and 4% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $92,747 per year, or $44.6 per hour.

Vice President, Global Head of Regulatory Affairs

Azurity Pharmaceuticals - US

Raleigh, NC • On-site

$145K - $192K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 22 days ago

Job description

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Overview
We are seeking a strategic and influential VP, Global Head of Regulatory Affairs to lead global regulatory strategy and execution across a diverse and complex portfolio. This role drives regulatory success from development through post-approval, ensuring timely submissions, approvals, and global compliance.
Key Responsibilities
  • Lead global regulatory strategy across multiple complex programs
  • Oversee regional regulatory teams and ensure high-quality compliant submissions
  • Direct global submissions and approvals while managing risks
  • Lead interactions and negotiations with FDA, EMA, and global regulators
  • Partner cross-functionally to align regulatory and market access strategies
  • Monitor regulatory trends and adapt development strategies
  • Ensure global compliance and oversee vendors/CROs
  • Build and lead a high-performing global RA organization
  • Communicate risks and strategic insights to leadership

Qualifications
  • MD, PhD, or PharmD preferred with 15+ years in Regulatory Affairs
  • Proven success in global regulatory submissions and approvals
  • Deep expertise across FDA, EMA, and international regulatory frameworks
  • Strong NCE and clinical development experience
  • Experience with 505(b)(2) and/or EU Hybrid pathways preferred
  • Experience leading major health authority interactions (e.g., pre-NDA/BLA, EOP2)
  • Strong leadership experience managing global regulatory teams
  • Expertise in GxP and global compliance requirements
  • Strategic thinker with strong problem-solving and execution skills
  • Excellent communication and stakeholder management skills
  • Experience in fast-paced or entrepreneurial environments is a plus

#LI-Hybrid
#LI-Full-time
Physical & Mental Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Must be able to sit for long periods of time
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
  • May occasionally climb stairs and/or ride elevators
  • The employee must occasionally lift and/or move up to 25 pounds
  • Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
  • Other miscellaneous job duties as required

Benefits We Offer:
  • Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
    • Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
    • Fuel Your Success: *Sales Only* - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
  • Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
  • Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *Excludes Sales, Manufacturing, and some Operations positions*
  • Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
  • Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
  • Meaningful Time with Your Loved Ones: We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge.
  • Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
  • Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
  • Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.

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