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

$190K - $240K *

Build and lead the Supplier Quality organization, ensuring external suppliers meet quality, engineering, and regulatory standards as the company transitions from prototype to commercial operations, fo...

3 weeks ago

  •   8 - 10 years exp.  •   Energy & Utilities

$117K - $184K *

Join a dynamic team to enhance CCI in packaging and medical devices, driving innovation and method development while providing critical support to late-stage projects and global manufacturing operatio...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Drive process excellence in Regulatory Affairs by managing issue resolution, ensuring compliance, and enhancing operational efficiency through cross-functional collaboration and strategic oversight...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$143K - $185K *

Lead regulatory strategies for T-cell and LVV products, ensuring compliance and quality across all development stages. Collaborate with cross-functional teams to drive submissions and support manufact...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$143K - $185K *

Lead regulatory strategies for T-cell and LVV products, ensuring compliance and quality across all development stages. Collaborate with cross-functional teams to drive submissions and support manufact...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$74K - $118K *

Join us to enhance quality control processes in a dynamic cGMP laboratory. You'll lead method transfers, train analysts, and ensure compliance while executing critical testing for raw materials and fi...

2 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$150K - $180K *

Lead the charge in regulatory strategy for oncology advertising, guiding cross-functional teams to enhance business initiatives. Utilize industry insights to drive innovation and ensure compliance wit...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$145K - $175K *

Join a team that's shaping the future of oncology advertising and promotion. Lead cross-functional initiatives, drive strategic decisions, and leverage industry knowledge to enhance business opportuni...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$145K - $175K *

Lead cross-functional teams to develop and execute regulatory strategies in oncology advertising and promotion. Drive initiatives, analyze market trends, and enhance communication across departments t...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$140K - $165K *

Join a team that's redefining regulatory compliance in advertising and promotion. This role focuses on DTC communications, ensuring compliance while collaborating with cross-functional teams to enhanc...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$70K - $95K *

Develop and maintain the Quality Management System, ensuring compliance and supporting continuous improvement across quality processes in a regulated environment...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$150K - $214K *

Lead complex global regulatory project management activities, ensuring alignment across functions and successful submission milestones. Drive operational excellence and best practices to support a gro...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Champion the validation and qualification of packaging operations, ensuring compliance with cGMP standards. Collaborate with cross-functional teams to uphold equipment and system integrity while drivi...

4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$187K - $208K *

Transform the CMC regulatory landscape for small molecules, guiding strategies from clinical development to market. Collaborate cross-functionally, author key submissions, and mentor junior staff whil...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Drive your career forward by joining our Global Regulatory Team, where you'll define and execute strategies for rare disease treatments, ensuring alignment with health authorities and contributing to...

4 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$168K - $268K *

Join a dynamic team to deliver strategic CMC regulatory support across diverse therapeutic modalities, ensuring successful clinical trials, market registrations, and compliance. Build collaborative re...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$168K - $268K *

Help us develop and execute global regulatory CMC strategies for clinical trials and market approvals by leveraging technical knowledge and fostering teamwork across research, manufacturing, and regul...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $125K *

Transform quality management systems by leading QMS activities, driving compliance, and implementing process improvements across engineering and operations. Collaborate cross-functionally to ensure re...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$145K *

Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...

United StatesRemote

Reposted 6 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$88K - $105K *

Elevate the quality assurance process by independently reviewing analytical and microbiological data, ensuring compliance with regulatory standards, and supporting batch disposition in a dynamic cGMP...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Drive regulatory connectivity initiatives by coordinating project activities, ensuring compliance, and enhancing data governance across cross-functional teams in a dynamic banking environment...

Yesterday

  •   8 - 10 years exp.  •   Staffing

$220K - $275K *

Elevate your career by leading global CMC regulatory strategies for biologics. Collaborate with cross-functional teams, ensure compliance, and drive successful product development while mentoring a hi...

United StatesRemote

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $153K *

Champion quality systems and compliance in a global organization, ensuring regulatory readiness and customer support. Collaborate with stakeholders to maintain documentation and resolve complex qualit...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$92K - $176K *

Unlock your potential by leading QA validation strategies for laboratory and manufacturing equipment. Drive compliance, manage budgets, and collaborate with teams to ensure operational excellence in a...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$114K - $212K *

Transform quality assurance processes by embedding risk-based controls and driving operational excellence in manufacturing, packaging, and warehouse operations, ensuring compliance with global standar...

Yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

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.