Senior Regulatory Affairs Specialists are pivotal in ensuring the successful clearance and compliance of products in the global healthcare scene. Their role involves compiling, reviewing, and submitting regulatory documents to government bodies. They ensure that their companies comply with all of the regulations and laws pertaining to their business. Browse through our extensive list of senior regulatory affairs specialist positions in top companies across the country.
Senior Regulatory Affairs Specialists analyze and coordinate the collection of scientific data to be shown in product labeling, investigator brochures, and new drug applications. They also revise product labeling and documentation to ensure compliance with regulatory standards and review the results of laboratory, animal, and human clinical testing trials to determine if they satisfy regulatory requirements.
To become a successful Senior Regulatory Affairs Specialist, strong analytical and communication skills, a keen eye for detail, and a strong background in regulations are required. Mastery of regulatory requirements and dedication to continued learning is crucial for success in this role.
Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have
$56K - $115K *
Pioneer regulatory CMC strategies while leading cross-functional teams in the pharmaceutical industry. This role will focus on lifecycle management and submissions across US, CA, and EU markets, ensur...
1 week ago
Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have
$56K - $115K *
Advance regulatory strategy and submissions for CMC in pharmaceuticals, collaborating with cross-functional teams to ensure compliance with FDA, EMA, and ICH standards while overseeing product lifecyc...
1 week ago
Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have
$120K - $145K *
Unlock global regulatory success by leading CMC strategies for small molecules. Collaborate across teams to ensure compliance and facilitate submissions, driving progress and innovation in product dev...
2 weeks ago
Manager, Regulatory Affairs (Ad-Promo)
$110K - $130K *
Empower regulatory excellence by managing promotional materials compliance across global markets, ensuring adherence to laws and internal policies, while aligning with strategic business objectives in...
6 days ago
Senior Quality Specialist, Technical
$95K - $124K *
Transform quality assurance processes by overseeing validation documentation and cross-functional collaboration to ensure compliance and safety for solid oral and biologic products in clinical and com...
3 weeks ago
Senior Director, Regulatory Affairs, Pulmovant
$160K - $200K *
Champion global regulatory strategies by providing expert support from development to approval. Lead cross-functional teams and ensure compliance with US and international regulations while fostering...
1 week ago
Manager, Regulatory Affairs (CMC)
$120K - $145K *
Champion CMC regulatory submissions by authoring high-quality dossiers for radiopharmaceuticals and biopharmaceuticals, ensuring compliance and collaboration across teams throughout the product lifecy...
5 days ago
$78K - $95K *
Transform compliance through expertise in HR regulations, policy management, and training. Support a culture of accountability while navigating multi-state employment laws across diverse teams, ensuri...
Reposted 5 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...
2 days ago
Associate Director, Regulatory Affairs
$164K - $225K *
Unlock potential by shaping global regulatory strategies that enable successful product launches. Collaborate across functions to ensure compliance and lead innovative submission processes throughout...
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...
5 days ago
Senior Manager, Regulatory Affairs – Animal Health Labeling
$76K - $119K *
Transform the regulatory landscape by leading labeling efforts for animal health products, ensuring compliance and excellence throughout the product lifecycle while collaborating with cross-functional...
1 week ago
Sr Specialist Medical Affairs (Remote)
$110K - $130K *
Join a team that's dedicated to optimizing medical operations and enhancing collaboration across global strategies. Drive impactful initiatives in research coordination and medical education while ens...
3 weeks ago
Global Regulatory Strategy Specialist
$77K - $113K *
Unlock potential by shaping global regulatory strategies and driving advocacy initiatives. Collaborate across teams to manage regulatory risks, assess opportunities, and provide strategic insights tha...
3 weeks ago
R&D and Regulatory Systems Lead
$95K - $193K *
Join a team that's driving innovation in R&D and Regulatory processes. Leverage your Veeva RIM expertise, manage global compliance systems, and implement solutions that meet dynamic business needs whi...
Reposted 5 days ago
Principal Specialist - Quality Validation
$110K - $130K *
Champion the integrity of IT Validation & Compliance within a CDMO, ensuring adherence to cGMPs and regulatory standards by overseeing enterprise software validation and reviewing critical quality del...
1 week ago
$146K - $182K *
Transform regulatory strategies in FDA Pharma and IVDR, ensuring compliance and driving product approvals. Collaborate with cross-functional teams, mentor associates, and enhance processes to support...
Yesterday
Senior Clinical Research Associate
$95K - $115K *
Advance your career by leading clinical research projects and ensuring compliance with timelines and standards. Collaborate with stakeholders and clinical sites to safeguard subjects' rights and data...
6 days ago
Compliance and Regulatory Specialist
$70K - $100K *
Address compliance and regulatory operations for Medicaid, ensuring accurate credentialing, monitoring regulations, and drafting policies to align with state requirements, while serving as the go-to s...
1 week ago
Associate Director, Global Regulatory Labeling and Ad Promo
$155K - $190K *
Drive your career forward by leading regulatory labeling and compliance strategies in a dynamic role that collaborates across teams to ensure successful product lifecycle management and adherence to i...
2 weeks ago
$150K - $180K *
Join a team that's shaping global regulatory strategy for rare disease therapies. In this pivotal role, you'll lead submissions and agency interactions across the US, EU, UK, and Japan, driving execut...
3 days ago
Senior Regulatory Operations Specialist (Remote)
$86K - $123K *
Elevate global regulatory submission processes by leading planning, delivery, and compliance efforts. Engage with cross-functional teams to ensure accurate dossiers for development and post-approval a...
3 weeks ago
Senior Country Approval Specialist
$100K - $120K *
Optimize regulatory submission processes as a key contact for country strategies. Collaborate with internal teams and local authorities to ensure timely compliance and proactive issue resolution, driv...
1 week ago
Associate Director, Regulatory Affairs (CMC)
$164K - $213K *
Accelerate progress at the forefront of regulatory affairs, leading CMC strategy and submissions for development and post-approval programs across the EMEA region. Collaborate cross-functionally to en...
Reposted 4 weeks ago
$150K - $180K *
Lead the development and execution of global CMC regulatory strategies, ensuring compliance from discovery through commercialization. Collaborate with cross-functional teams to address regulatory requ...
2 weeks ago
What does a Senior Regulatory Affairs Specialist do?
Senior Regulatory Affairs Specialists ensure product compliance with regulatory agencies. They compile and submit documentation required for clearance, perform internal audits, and ensure the business adheres to relevant laws and regulations.
What skills are needed for a Senior Regulatory Affairs Specialist job?
Key skills include knowledge of regulatory requirements, strong analytical and communication skills, attention to detail, and a commitment to continuous learning.
Where can I find Senior Regulatory Affairs Specialist jobs?
You can find top Senior Regulatory Affairs Specialist jobs that pay $100k and up on Ladders.
How can I progress in a Senior Regulatory Affairs Specialist career?
Progression can be achieved through continuous learning, keeping abreast of changes in regulations, obtaining relevant certifications, and gaining experience in various regulatory affairs roles.