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.

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$140K - $180K *

Join as a pivotal member driving NGS strategy, advocating for High-Plex Sequencing solutions, and becoming a trusted expert in the life sciences market. Forge lasting customer relationships while expa...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$140K - $180K *

Join a team that's shaping the future of next-generation sequencing. As a key technical authority, you’ll drive market growth, develop end-to-end workflows, and foster relationships with leading resea...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$82K - $105K *

Optimize your career as you manage and negotiate contracts, collaborate with legal teams, and assess business risks. Leverage your experience in environmental remediation and build effective client re...

Reposted 3 weeks ago

  •   8 - 10 years exp.  •   Business Services

$97K - $120K *

Elevate contract management by negotiating and administering complex agreements, ensuring compliance, and mitigating risks while collaborating with legal and internal teams to support business operati...

Reposted 3 weeks ago

  •   8 - 10 years exp.  •   Business Services

$114K - $157K *

Transform quality assurance processes for IVD product development, ensuring compliance with FDA, ISO, and other relevant regulations. Lead cross-functional collaborations and continuous improvement in...

1 month ago

  •   5 - 7 years exp.  •   Healthcare

$80K - $95K *

Join a team that's dedicated to ensuring contractor compliance through quality assurance methods, audits, and process improvements, while supporting global manufacturing and modernization efforts acro...

3 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$85K - $107K *

Champion effective contract administration through comprehensive review, negotiation, and compliance management, ensuring seamless collaboration with legal, technical, and business units to mitigate r...

Reposted 3 weeks ago

  •   8 - 10 years exp.  •   Business Services

$135K - $145K *

Unlock potential by leading site-level compliance programs ensuring products meet quality and regulatory standards. Guide audits and inspections, manage CAPAs, and foster a culture of accountability a...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$114K - $210K *

Champion regulatory document development for global submissions, ensuring compliance with ICH guidelines and corporate objectives. Lead projects, mentor junior staff, and enhance cross-functional coll...

RemoteRemote

Yesterday

  •   5 - 7 years exp.  •   Healthcare

$110K - $130K *

Shape the future of advanced RF systems integration and testing. Collaborate with experts to ensure seamless hardware and software functionality, leveraging cutting-edge tools and methodologies in a d...

Today

  •   5 - 7 years exp.  •   Staffing

$128K - $210K *

Engineer impactful pharmacometric analyses for drug development, collaborating cross-functionally. Apply advanced methodologies in pharmacokinetics and pharmacodynamics to inform critical development...

4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$128K - $210K *

Champion the execution of advanced pharmacometric analyses, enabling strategic drug development through collaboration and cutting-edge quantitative techniques. Contribute meaningful insights across pr...

4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$128K - $210K *

Unlock potential by leveraging your quantitative pharmacology expertise to shape drug development through innovative pharmacometric analyses and strategic collaboration across cross-functional teams...

4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$108K - $153K *

Transform your career by leading new product development, ensuring quality engineering excellence from concept to launch. Collaborate cross-functionally to enhance innovative designs and impact in a d...

Reposted 1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$83K *

Shape quality assurance processes by developing standards, leading audits, analyzing performance, and driving continuous improvement initiatives for product and process excellence...

3 weeks ago

  •   Less than 5 years exp.  •   Energy & Utilities

$83K - $105K *

Partner with us to support complex sourcing and acquisition tasks, ensuring compliance with federal regulations while fostering strong supplier relationships and enhancing supply chain efficiency...

2 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$73K - $104K *

Drive quality excellence by leading risk management and compliance initiatives across the organization. Collaborate with cross-functional teams to enhance Quality Management Systems and ensure adheren...

Yesterday

  •   5 - 7 years exp.  •   Aerospace & Defense

$110K - $130K *

Shape the future of medical product management by overseeing FDA regulatory coordination, clinical protocol development, and investigational product management, ensuring compliance and stakeholder eng...

3 weeks ago

  •   Less than 5 years exp.  •   Business Services

$178K - $307K *

Lead the development of integrated commercial strategies for a diverse product portfolio, managing a team to drive marketplace success through collaboration across functions and effective execution of...

Yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$178K - $307K *

Reimagine the future of pharmaceutical marketing by leading a dynamic team to develop and execute integrated strategies for a diverse product portfolio, driving commercial success through collaboratio...

Yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Lead the charge in advancing biologic therapies by designing robust purification processes. Collaborate with cross-functional teams to drive drug substance development and ensure successful clinical m...

2 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$88K - $105K *

Accelerate progress at our laboratories by leading the Lean culture initiatives. Drive continuous improvement, enhance operational excellence, and foster a disciplined problem-solving culture as you c...

3 weeks ago

  •   5 - 7 years exp.  •   Food & Beverages

$80K - $95K *

Join a dynamic team to oversee document control for a major water infrastructure project. Ensure compliance, maintain records, and support construction management efforts in a fast-paced environment...

3 weeks ago

  •   Less than 5 years exp.  •   Technical Services

$84K - $156K *

Accelerate your career by ensuring supplier quality performance and driving process improvements. Collaborate with internal teams and external suppliers to meet engineering and manufacturing standards...

3 weeks ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$84K - $156K *

Join a dynamic team as you ensure supplier quality performance, drive process improvements, and collaborate with internal and external partners to meet engineering and manufacturing standards in a hig...

3 weeks ago

  •   Less than 5 years exp.  •   Aerospace & Defense

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.