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.
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.
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.
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.
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.
Spécialiste Conformité Réglementaire
$80K - $95K *
Manage and maintain quality systems to ensure compliance while driving process improvement and operational efficiency across teams, focusing on CAPA, audits, and vendor management to support continuou...
3 weeks ago
$105K - $164K *
Champion quality excellence in a dynamic pharmaceutical environment. Lead a team to ensure compliance with regulations and drive continuous improvement initiatives while overseeing quality operations...
5 days ago
$80K - $95K *
Optimize quality management systems by ensuring compliance and enhancing processes. Collaborate with cross-functional teams to drive continuous improvement and support audits, while managing document...
1 week ago
Senior Director, Regulatory Operations
$265K - $295K *
Elevate regulatory operations by managing submission strategies and compliance processes. Lead cross-functional teams to ensure timely, high-quality submissions while adapting to evolving regulations...
Reposted 2 days ago
Senior Director, Regulatory Operations
$265K - $295K *
Lead the charge in regulatory operations, managing submission strategies and compliance processes. Collaborate across teams to ensure timely, high-quality submissions while optimizing regulatory syste...
Reposted 2 days ago
Senior Director, Regulatory Operations
$265K - $295K *
Lead the charge in regulatory operations, managing submissions and compliance strategies to ensure global regulatory alignment and efficiency across multiple teams and projects...
Reposted 2 days ago
$62K - $100K *
Unlock your potential as a Quality Agreement Specialist, ensuring compliance and quality in pharmaceutical operations. Collaborate with teams to enhance processes, support audits, and resolve quality...
5 days ago
Aseptic and Qualification Project Specialist
$98K - $183K *
Join a team that's shaping the future of aseptic manufacturing training. Lead initiatives to enhance technical skills and qualifications, collaborating with experts to develop impactful training progr...
3 days ago
Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote)
$90K - $135K *
Unlock potential by leading regulatory compliance for IVD products, ensuring adherence to global standards. Collaborate with cross-functional teams to assess risks, manage adverse events, and drive co...
1 week ago
Regulatory Affairs Manager (CMC and/or Oncology)
$111K - $161K *
Help us lead regulatory strategies in oncology, ensuring timely approvals and compliance. Collaborate with cross-functional teams and build trust with Health Canada to streamline submissions and enhan...
4 weeks ago
$120K - $165K *
Strategize regulatory initiatives to align with business goals, ensuring compliance and successful product lifecycle management. Lead cross-functional teams, assess risks, and drive effective regulato...
1 week ago
Global Regulatory Affairs Director - Inflammation and Rare Disease
$189K - $256K *
Join a global team to shape regulatory strategies in biotechnology, supporting product development and lifecycle management in Inflammation and Rare Diseases. Lead regulatory efforts, ensure complianc...
3 weeks ago
Senior Associate, Regulatory Affairs Submission Management - Hybrid
$100K - $120K *
Empower cross-functional teams by managing complex regulatory submission projects, ensuring timely delivery of high-quality dossiers that meet regulatory standards and enhance collaboration across dep...
2 days ago
Senior Associate, Regulatory Affairs Submission Management - Hybrid
$95K - $115K *
Oversee medium to high impact regulatory submission projects, ensuring timely delivery of high-quality dossiers. Collaborate with cross-functional teams, manage timelines, and facilitate meetings to e...
2 days ago
Senior Director, Regulatory Affairs (Oncology)
$248K - $352K *
Transform global regulatory strategies to meet asset goals and health authority requirements. Collaborate across teams to ensure high-quality submissions and mitigate risks while driving compliance in...
Reposted 3 weeks ago
Regulatory Writing Senior Manager
$139K - $188K *
Unlock potential by leading regulatory writing for complex submissions, mentoring junior writers, and driving departmental initiatives. Collaborate with cross-functional teams to ensure compliance and...
1 week ago
Senior MES Quality Validation Specialist
$70K - $110K *
Lead the charge in ensuring compliance and quality for MES changes. Collaborate with cross-functional teams to validate systems, manage risk, and maintain inspection readiness, all while driving a maj...
1 week ago
$95K - $115K *
Champion quality excellence by leading manufacturing and supplier quality initiatives, implementing robust QMS, and driving continuous improvement across high-volume operations to enhance product reli...
2 weeks ago
$110K - $130K *
Champion quality engineering initiatives in product development, ensuring compliance with regulatory standards. Collaborate across teams to enhance design verification and process validation while mai...
3 weeks ago
Supervisor, Quality Assurance Specialist
$78K - $128K *
Drive quality assurance excellence by leading compliance activities, mentoring staff, and collaborating with external partners to ensure product integrity and adherence to regulatory standards in a dy...
2 weeks ago
Sr. Specialist, Quality Control Raw Materials
$74K - $118K *
Join a dynamic team to oversee QC Raw Material activities, ensuring compliance with GMP standards. Drive continuous improvement and manage projects while collaborating across functions to support manu...
2 weeks ago
Senior Specialist, External Quality Operations
$80K - $129K *
Engage in quality operations for externally manufactured pharmaceutical products, managing relationships with CMOs and cross-functional teams. Ensure compliance, oversee batch reviews, and drive conti...
1 week ago
Senior Specialist, External Quality Operations
$80K - $129K *
Join us to oversee external quality operations for pharmaceutical products, ensuring compliance and excellence in batch review, supplier management, and quality support. Collaborate with cross-functio...
1 week ago
Senior Specialist, External Quality Operations
$80K - $129K *
Lead the charge in managing external quality operations for pharmaceutical products, ensuring compliance and effective communication with CMOs. Drive continuous improvement and support quality initiat...
1 week ago
Associate Principal Engineer, Drug-Device Combination Products
$142K - $224K *
Lead the charge in complex device development programs, orchestrating cross-functional teams to deliver innovative combination products from concept to launch while ensuring regulatory compliance and...
1 week ago
What does a senior regulatory affairs specialist do?
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?
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?
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?
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?
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.