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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$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

$80K - $200K *

Champion the transformation of MedTech Regulatory Processes by leading RIM implementations and ensuring client success through tailored solutions. Collaborate across teams to enhance adoption of innov...

Reposted 1 week ago

  •   8 - 10 years exp.  •   Consumer Technology

$80K - $200K *

Unlock potential by leading MedTech RIM implementations globally, transforming regulatory processes through innovative technology while ensuring successful customer adoption and collaboration across t...

Reposted 3 weeks ago

  •   8 - 10 years exp.  •   Consumer Technology

$108K - $130K *

Champion innovative space programs by providing expert contract support, ensuring compliance and effective acquisition strategies. Collaborate with government leadership to manage complex federal cont...

2 weeks ago

  •   11 - 15 years exp.  •   Information Technology

$86K - $165K *

Accelerate progress at the heart of aerospace procurement, ensuring material readiness and production success. Collaborate across teams to manage supply chain processes, evaluate suppliers, and resolv...

Reposted yesterday

  •   Less than 5 years exp.  •   Aerospace & Defense

$120K - $145K *

Lead innovation in sterile pharmaceutical packaging operations, managing design, commissioning, and optimization processes. Collaborate with engineering teams to enhance production efficiency and ensu...

4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Engage in packaging operations within a sterile pharmaceutical environment. Lead teams, design specifications, troubleshoot, and implement innovations to enhance processes, ensuring compliance and eff...

4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Shape the future of pharmaceutical packaging operations by leading design, commissioning, and optimization projects within a sterile manufacturing environment. Collaborate with engineers and stakehold...

4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Lead packaging operations in the pharmaceutical industry, overseeing design, commissioning, and optimization of systems in a sterile environment. Drive efficiency and innovation while collaborating wi...

4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$165K - $185K *

Transform partner audit experiences by leading cross-functional teams to streamline processes, enhance compliance, and drive timely resolutions. This role is pivotal in ensuring seamless collaboration...

2 weeks ago

  •   8 - 10 years exp.  •   Business Services

$119K - $186K *

Lead product quality engineering efforts for medical devices, ensuring compliance and excellence in investigations, risk assessments, and mentoring. Collaborate cross-functionally to drive improvement...

3 days ago

  •   8 - 10 years exp.  •   Healthcare

$157K - $256K *

Join a dynamic team to lead the Integrated Data Review strategy, ensuring quality and compliance in clinical data management. Drive innovation and mentor a skilled team while collaborating across depa...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$157K - $256K *

Drive the execution of data validation strategies, ensuring quality and compliance through effective oversight, collaboration, and continuous improvement initiatives across clinical data domains...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$137K - $195K *

Unlock potential by driving sales and business development for innovative bioprocessing solutions. Collaborate with key accounts and internal teams to enhance customer satisfaction and market presence...

RemoteRemote

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$136K - $195K *

Drive revenue growth and market adoption of chromatography columns. Engage with biopharmaceutical manufacturers to support process development and commercialization, while building strong relationship...

RemoteRemote

1 month ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Manage complex quality assurance initiatives, ensuring compliance with aerospace and DoD standards. Lead project teams to deliver defect-free products while mentoring staff and driving continuous impr...

1 week ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$89K - $148K *

Drive the design and development of electrical components for robotic systems, ensuring integration and performance through collaboration with cross-functional teams and adherence to quality standards...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$94K *

Empower quality and compliance initiatives by collaborating across teams to enhance manufacturing performance and product quality. Drive continuous improvement through effective oversight, innovative...

Cambridge, ONIn-Person

Reposted 2 days ago

  •   5 - 7 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.