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Regulatory Strategy Jobs in Raleigh, NC (NOW HIRING)

Osv_bioventus

Regulatory Affairs Manager

Durham, NC · On-site

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

NCBiotech

Regulatory Affairs Manager

Durham, NC · On-site

$100 - $150/hr

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

Bioventus

Regulatory Affairs Manager

Durham, NC · On-site

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

UPL Limited

US Regulatory Manager

Cary, NC · On-site

Has developed regulatory strategies to obtain, maintain, and defend active ingredients and product registrations with federal and state authorities * Has demonstrated ability to work independently ...

Clorox

Regulatory Affairs Specialist II

Durham, NC

Identify regulatory risks early and propose mitigation strategies. * Support licensing activities, as needed. Oversee Brand Maintenance & Lifecycle Management (25%) * Provide ongoing regulatory ...

GSK

Regulatory Compliance Lead

Zebulon, NC · On-site

Create an environment where strategic decision making is encouraged in order to drive site regulatory compliance for all new and existing products. * Manage the Periodic Product Review (PPR) Program ...

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All JobsRegulatory Strategy JobsRegulatory Strategy Jobs in Raleigh, NC

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.

Regulatory Affairs Manager

Osv_bioventus

Durham, NC • On-site

Full-time

Re-posted 7 days ago

Job description

Are you ready to work for a more active world?

At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

The Regulatory Affairs Manager is responsible for developing and executing global regulatory strategies to plan, prepare, and obtain approvals and compliance with national and international regulatory requirements (e.g. U.S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory expertise. The position will ensure that company policies, procedures and practices follow appropriate regulatory requirements.

Key Responsibilities:
1. Prepare, provide direction and oversee documentation packages for submission to global regulatory authorities to register new and/or maintain global approvals/clearances for assigned products.

2. Develop and maintain outstanding relationships with all regulatory and compliance agencies. Provide appropriate interface with global regulatory agencies in a variety of pre- and post-market forums. Provide guidance, interpretation, and opinions on complex regulatory matters (particularly related to submission pathways), outlining the different outcomes.
3. Prepares, collects, reviews, and assembles technical documentation required for writing regulatory and clinically-related submissions such as US 510K, PMAs, IDEs, NDAs, INDs, or international dossiers for new and modified products.
4. Liaises with project teams to develop regulatory strategies, testing requirements and other documentation to ensure regulatory data requirements are met..
6. Works with stakeholders to serve as a point person for regulatory agency interactions, including preparation of briefing packages, including presentations, and strategy for meetings, and response to agency letters pertaining to assigned products.

7. Monitor proposed and current global regulations and standards; assess impact of changes to such on assigned biologics product lines

8. Maintains awareness of global regulatory legislation and assesses its impact of development and manufacturing initiatives.

9. Evaluates design, manufacturing and labeling changes to ensure compliance with FDA, international, and other applicable governmental regulations.

10. Identifies and facilitates in the remedy of inefficiencies in Quality systems and processes.

11. Contribute to the Regulatory and/or Quality perspective on due diligence activities to identify issues related to the targeted product's development and/or its manufacture.

12. Holds oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.

13. All other duties or projects as assigned.


Education and Experience (Knowledge, Skills & Abilities)

  • Bachelor's degree required (study area in Engineering or life sciences preferred, but other degrees may be considered)

  • Knowledge & experience working with biologics

  • Extensive knowledge of FDA and applicable international regulations required.

  • Working knowledge of US Quality Systems Regulations (QSRs) and/or Good Manufacturing Practices (GMPs), along with ISO 13485.

  • Minimum of 5 - 7 years of Regulatory and Quality regulations experience and submission experience required. Class II medical device experience required, Class III medical device and/or PMA / BLA/NDA submissions experience desired.

  • Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing

  • Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive

  • Being detail-oriented while having the ability to handle multiple projects/tasks

  • Experience interacting with US FDA is required

Are you the top talent we are looking for?

Apply now! Hit the "Apply" button to send us your resume and cover letter.

Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms ofdiversity andtake pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation.All individuals, regardless of personal characteristics, are encouraged to apply.

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