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.
Sr. Clinical Research Associate (Cardiac Catheter Products)
$95K - $115K *
Join a team that's dedicated to advancing clinical research efforts, managing studies with a focus on regulatory compliance, data integrity, and patient safety across international sites. Make a signi...
3 weeks ago
$115K - $140K *
Elevate quality assurance in software delivery. Collaborate with cross-functional teams to enhance testing strategies, drive automation, and ensure high-quality releases, utilizing your expertise to m...
2 weeks ago
Senior Manager, Sales-Pharma Solutions (Lonza - Capsugel)
$142K - $165K *
Join a dynamic team to drive pipeline growth and expand customer relationships in pharmaceutical solutions. Collaborate with cross-functional teams to ensure exceptional project execution and commerci...
3 weeks ago
$62K - $107K *
Drive accurate health benefit plan configurations within a TPA system, ensuring compliance with client requirements and plan documents. Validate, test, and enhance processes to streamline claims adjud...
4 days ago
Senior Director, Inspection Readiness
$160K - $200K *
Elevate inspection readiness and GCP compliance by leading cross-functional teams. Proactively identify operational gaps and implement effective solutions across global clinical trials, ensuring high...
1 week ago
Senior Project Manager (Rare Disease)
$122K *
Engage with a dynamic project team to manage complex clinical trials, ensuring budget adherence and project delivery while developing strong client relationships in the Rare Disease sector...
Reposted 2 weeks ago
Senior Property Resolution Specialist (Property Claims Field Adjuster)
$61K - $98K *
Lead the investigation and processing of property claims, ensuring thorough evaluations and on-site inspections. Engage with clients and assess risks while handling personal and commercial losses, con...
2 weeks ago
Remote Regional Sales Manager - Biochemistry & Life Sciences
$70K - $100K *
Accelerate business growth by developing new customer relationships in the biochemistry and life sciences sector. Own your territory, manage sales pipelines, and help clients access essential products...
1 week ago
$120K - $180K *
Contribute to the compliance framework and processes for regulated facilities. Collaborate with multi-disciplinary teams to achieve regulatory commitment while ensuring safe and efficient operations o...
Reposted 2 days ago
Sales Specialist Mass Spectrometry
$117K - $208K *
Drive high-performance Mass Spectrometry solutions in commercial, government, and academic sectors. Collaborate with teams to create opportunities and strategies, ensuring success in a competitive mar...
Today
Sales Specialist Mass Spectrometry
$117K - $195K *
Unlock potential by driving laboratory efficiency through consultative sales of mass spectrometry solutions. Collaborate with teams to enhance workflows and customer success while representing innovat...
3 days ago
$71K - $142K *
Seek to drive excellence in clinical trial site contracts by leading negotiations, developing agreements, and fostering collaborations with key stakeholders throughout the contract lifecycle while ens...
3 weeks ago
$65K - $116K *
Lead middle revenue cycle improvements by managing client medical coding operations, ensuring quality compliance, and optimizing team performance. Drive strategic initiatives while fostering a collabo...
2 weeks ago
$110K - $130K *
Shape the future of radiation safety and compliance, driving initiatives across a national network. Lead audits, foster mentorship, and ensure adherence to evolving regulations while collaborating wit...
2 weeks ago
$159K - $199K *
Champion the Great Lakes initiatives by leading resilient climate planning and forging partnerships. Utilize data-driven insights to craft strategic recommendations while collaborating with multidisci...
1 week ago
Sr. TMF Specialist (Contractor)
$100K - $120K *
Champion regulatory excellence by managing the Trial Master File (TMF) to ensure compliance with Good Clinical Practice (GCP) and other regulations. Collaborate with study teams to maintain inspection...
5 days ago
Managing Consultant - Life Sciences Advisory - Market Access (US)
$122K - $204K *
Manage and implement comprehensive pricing and access strategies in the pharmaceutical sector, leading project teams and maintaining robust client relationships while overseeing multiple initiatives a...
2 weeks ago
Senior Market Research Analyst
$88K - $105K *
Unlock your potential as a Senior Analyst, driving customer experience insights through data analysis. Collaborate across teams to identify trends, develop narratives, and support strategic decision-m...
3 days ago
Senior Site Contract Specialist
$95K - $115K *
Join a team that's integral to the contract negotiation process, ensuring effective collaboration with sites and internal teams while managing risks and compliance. Play a key role in mentoring junior...
3 weeks ago
Account Specialist (Louisville, KY)
$160K - $192K *
Lead the charge in driving commercial success by fostering key relationships, supporting product launches, and navigating patient care pathways while collaborating with cross-functional teams to enhan...
5 days ago
Field Supplier Quality Manager (Remote)
$107K - $204K *
Unlock potential by leading supplier quality initiatives, driving performance improvements, and collaborating cross-functionally to resolve issues. Utilize analytical skills to enhance supplier relati...
3 days ago
Senior Nurse Case Manager – Rare Disease
$76K - $119K *
Partner with us to enhance patient care by managing comprehensive case support across healthcare settings. Utilize your nursing expertise to coordinate services, ensure patient adherence, and drive ef...
6 days ago
$101K - $136K *
Transform clinical documentation by crafting high-quality regulatory submissions. Collaborate with cross-functional teams to ensure compliance with FDA and ICH guidelines while managing timelines and...
3 days ago
Project Manager, REMS Team - Remote based in the US
$100K - $120K *
Manage and lead cross-functional teams to deliver complex projects effectively, ensuring adherence to timelines, budgets, and quality standards while fostering strong communication with stakeholders a...
2 weeks ago
$110K - $130K *
Accelerate progress at the forefront of clinical research by leading studies, managing collaborations, and overseeing regulatory compliance to deliver impactful evidence generation strategies for medi...
4 days 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.