Senior Regulatory Affairs Specialist Jobs

Explore senior regulatory affairs specialist jobs with organizations seeking experienced professionals to guide products through complex regulatory requirements. These roles combine subject-matter expertise, strategic judgment, and cross-functional leadership to support compliant product development and market access. Ladders features vetted professional opportunities paying $100,000 or more.

What Senior Regulatory Affairs Specialists Do

Senior regulatory affairs specialists interpret regulations and guidance, assess how requirements affect products and business plans, and coordinate regulatory activities across the product lifecycle. Depending on the industry, they may prepare and review submissions, maintain regulatory documentation, support audits and inspections, and communicate with regulatory agencies. They also help teams identify risks early and keep programs aligned with applicable standards.

Common Responsibilities and Skills

Responsibilities vary by employer and sector, but often include developing regulatory strategies, managing submission timelines, reviewing technical and labeling materials, tracking regulatory changes, and advising partners in quality, clinical, research, manufacturing, and commercial teams. Employers may look for strong writing and project-management skills, careful attention to detail, sound judgment, and experience with relevant regulations and submission processes.

Industries and Career Opportunities

Senior regulatory affairs specialists work across fields such as pharmaceuticals, biotechnology, medical devices, diagnostics, and other regulated industries. Their experience can lead to opportunities in regulatory strategy, program leadership, regulatory operations, quality, or people management. Scope and job requirements depend on the organization, product type, and markets served.

Find Senior Regulatory Affairs Specialist Jobs

Browse senior regulatory affairs specialist opportunities on Ladders to discover vetted roles paying $100,000 or more. Compare responsibilities, qualifications, and work arrangements, then focus your search on positions that match your regulatory expertise and career goals.

Remote
caret down
Compensation
caret down
Position Level
caret down
Time Posted
caret down
Industries
caret down
Locations
caret down
More
1
caret down

$134K - $219K *

Transform enterprise planning by leading process standards and technical integration. Collaborate across functions to ensure effective use of planning tools, manage templates, and drive continuous imp...

5 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$178K - $307K *

Elevate quality management by leading CAPA processes and issue resolution. Drive continuous improvement initiatives across a global team, ensuring compliance and fostering a culture of accountability...

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$85K - $100K *

Take ownership of EHS programs in research labs, ensuring safety compliance, managing risks, and leading inspections. Collaborate on facility designs and oversee contractor safety, creating a proactiv...

4 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$105K - $168K *

Elevate your career by leveraging your expertise in communication and technical writing to support innovative medical device solutions. Collaborate with key opinion leaders and ensure compliance with...

2 days ago

  •   Less than 5 years exp.  •   Healthcare

$105K - $168K *

Explore a dynamic role requiring strong communication and analytical skills. Collaborate with clinical personnel and key opinion leaders while ensuring compliance with medical device regulations and c...

2 days ago

  •   Less than 5 years exp.  •   Healthcare

$82K - $156K *

Shape the future of medical device quality assurance by providing critical support in product development, compliance, and operational excellence. Collaborate with cross-functional teams to enhance qu...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$98K - $273K *

Optimize statistical programming processes by leading complex dataset development, ensuring compliance with CDISC standards, and mentoring junior programmers to enhance team performance and deliver hi...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$112K - $168K *

Contribute to innovative cell therapy product characterization by leading method development, analyzing complex datasets, and collaborating across teams to ensure quality and efficacy from preclinical...

Today

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$220K - $260K *

Unlock your potential by overseeing global regulatory submissions and compliance strategies. Lead cross-functional teams to ensure successful outcomes while driving project management excellence in a...

Yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Unlock your potential as a Technical Consultant, providing expert support in regulatory publishing systems and document management. Collaborate with teams and clients to troubleshoot issues, enhance s...

British Columbia, CARemote

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$115K - $182K *

Empower project management by providing expert guidance on labor relations, ensuring compliance with policies and laws while fostering positive relationships with union representatives and addressing...

5 days ago

  •   5 - 7 years exp.  •   Technical Services

$80K - $95K *

Lead the charge in ensuring compliance with global regulatory and quality standards for medical devices. Collaborate across teams to prepare essential documentation and support regulatory submissions...

2 days ago

  •   Less than 5 years exp.  •   Healthcare

$110K - $130K *

Join a dynamic team to lead regulatory strategies, ensuring compliance and driving product registrations. Collaborate with cross-functional teams to support growth initiatives and maintain strong rela...

2 weeks ago

  •   11 - 15 years exp.  •   Manufacturing & Automotive

$150K - $279K *

Empower government sector success by identifying sales opportunities and leveraging legal tech expertise. Join a dynamic team to boost revenue through strategic outreach and relationship building whil...

United StatesRemote

4 weeks ago

  •   Less than 5 years exp.  •   Media

$110K - $176K *

Join a dynamic team to enhance and implement Quality Systems, ensuring compliance and continuous improvement across projects. Collaborate with cross-functional teams to drive quality initiatives and d...

3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$110K - $130K *

Champion independent clinical monitoring for early-phase studies, ensuring data accuracy and regulatory compliance. Collaborate with cross-functional teams to support critical milestones and enhance p...

Yesterday

  •   5 - 7 years exp.  •   Staffing

$230K - $250K *

Lead innovative regulatory strategies for global product development, ensuring compliance and effective communication with health authorities. Collaborate cross-functionally to guide submissions and m...

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Transform quality assurance processes as a key leader in audits, ensuring compliance with regulatory standards and driving continuous improvement. Collaborate with teams to identify issues and develop...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$117K - $184K *

Lead the execution of capital projects in a dynamic team, focusing on process design and startup for high potency API projects. Collaborate across functions to ensure project success while adhering to...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Join us to lead complex safety projects, collaborate globally, and implement pharmacovigilance practices, ensuring product safety and efficacy while working independently and managing day-to-day CEC/D...

North Carolina, USRemote

5 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Advance equipment reliability and operational efficiency by leading engineering initiatives, collaborating with production teams, and implementing maintenance programs to minimize downtime and enhance...

3 weeks ago

  •   Less than 5 years exp.  •   Food & Beverages

$75K - $95K *

Analyze and develop compliance documentation for medical devices, ensuring alignment with regulatory standards. Collaborate with cross-functional teams to support product lifecycle activities and main...

2 days ago

  •   Less than 5 years exp.  •   Hospitals & Medical Centers

$110K - $112K *

Collaborate with cross-functional teams to drive product development for in vitro diagnostics, ensuring compliance with quality standards and timely project delivery while managing multiple initiative...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$120K - $145K *

Join a team that's dedicated to producing high-quality clinical supplies. Lead manufacturing operations, collaborate on formulation development, and ensure compliance with cGMP standards while driving...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$88K - $132K *

Join our team as a Senior Procurement Specialist, where you'll manage procurement processes, negotiate contracts, and ensure compliance with corporate policies. Collaborate with internal customers to...

Today

  •   5 - 7 years exp.  •   Enterprise Technology

Frequently Asked Questions (FAQ)

  • What does a senior regulatory affairs specialist do?question toggle

    A senior regulatory affairs specialist interprets applicable regulations, develops or supports regulatory strategies, coordinates submissions and documentation, and advises cross-functional teams on compliance throughout a product's lifecycle.

  • What qualifications are commonly required for senior regulatory affairs specialist jobs?question toggle

    Employers commonly seek relevant regulatory affairs experience, familiarity with regulations for the applicable industry and markets, strong written communication, project-management ability, and a related degree. Specific requirements vary by role and product area.

  • Which industries hire senior regulatory affairs specialists?question toggle

    Common employers include pharmaceutical, biotechnology, medical device, and diagnostics companies, as well as other organizations that develop or manage regulated products.

  • How much do senior regulatory affairs specialist jobs pay?question toggle

    Pay varies by employer, location, industry, and experience. Ladders focuses on vetted professional jobs paying $100,000 or more.

  • What career paths can follow a senior regulatory affairs specialist role?question toggle

    Experienced specialists may advance into regulatory strategy, regulatory program or operations leadership, management, or related quality and compliance roles, depending on their background and the employer.