Top Jobs for Senior Regulatory Affairs Specialists

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.

The Role of a Senior Regulatory Affairs Specialist

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.

Essential Skills for Senior Regulatory Affairs Specialists

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.

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$170K - $185K *

Champion regulatory initiatives for in vitro diagnostics, guiding submissions and strategy globally. Foster cross-functional collaboration to drive compliance and product approval while enhancing safe...

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$78K - $100K *

Join a team that's dedicated to enhancing import compliance by analyzing data, investigating discrepancies, and collaborating with customs brokers. Your role will ensure accurate entry processing and...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Drive regulatory excellence in the development and lifecycle of IVD medical devices. Collaborate with cross-functional teams to navigate FDA submissions and maintain compliance throughout the product...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$80K - $95K *

Lead the maintenance and improvement of HPLC systems and mass spectrometric detectors. Drive operational excellence through troubleshooting, training, and mentorship, while ensuring compliance with re...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Collaborate with cross-functional teams to drive regulatory strategies and manage submissions for drug products. Provide expert guidance to ensure compliance and oversee regulatory activities througho...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Partner with us to drive global CMC regulatory strategies for biologics and vaccines. Take ownership of submissions and lifecycle management. Collaborate closely across functions to ensure compliance...

US-AnywhereRemote

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Unlock potential by ensuring compliance with GMP regulations and quality standards. Collaborate with cross-functional teams to support quality events, tracking metrics, and inspection readiness while...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Accelerate regulatory excellence by leading strategies for product compliance and innovation. Drive submissions, manage audits, and mentor your team to foster a culture of continuous improvement in th...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$120K - $150K *

Transform sterility assurance practices by leading aseptic processing and maintaining compliance in clean room environments. Collaborate cross-functionally to enhance product quality and regulatory ad...

Reposted 4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$248K - $310K *

Unlock your potential in CMC regulatory leadership, driving strategies and managing global submissions for late-stage clinical assets while collaborating across functions to ensure compliance and time...

Reposted 1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$241K - $300K *

Lead the development and execution of global CMC regulatory strategies to support clinical asset advancement. Collaborate cross-functionally to ensure timely, high-quality submissions and health autho...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$265K - $285K *

Join us to shape global Regulatory CMC strategies, driving late-stage development and regulatory submissions across various programs while building a robust function to meet evolving compliance needs...

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Empower quality assurance operations by ensuring compliance with GMP, GLP, and regulatory standards. Drive system improvements, conduct audits, and support technical teams to enhance laboratory proces...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$150K - $180K *

Lead the charge in shaping global CMC regulatory strategies, ensuring quality submissions, and driving compliance across development programs while collaborating with cross-functional teams and health...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$132K - $172K *

Advance your career by leading CMC regulatory strategy for small molecule products, ensuring compliance across development and commercialization. Collaborate with cross-functional teams to align objec...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$132K - $172K *

Grow your expertise in CMC Regulatory Affairs, leading strategic initiatives for small molecule drug products from development through commercialization. Collaborate cross-functionally to align regula...

US-AnywhereRemote

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$83K - $144K *

Empower compliance excellence by leading cross-functional initiatives to ensure adherence to national security regulations. Collaborate with diverse teams to manage compliance processes and audits eff...

2 weeks ago

  •   5 - 7 years exp.  •   Telecommunications & Hardware

$125K - $150K *

Champion regulatory excellence by leading a high-performing team in strategic submission oversight and compliance, ensuring timely approvals for a diverse product portfolio across US and Canadian mark...

North York, ONIn-Person

Reposted 3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$88K - $105K *

Oversee the preparation of eCTD submissions, engage with clients and regulatory bodies, and ensure compliance with changing regulations. Contribute to the development and training of associates in reg...

4 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Shape the future by developing and qualifying injection molding processes while ensuring quality and compliance in a dynamic medical device environment. Lead mold design reviews and collaborate with s...

1 week ago

  •   8 - 10 years exp.  •   Healthcare

$211K - $250K *

Transform the future of regulatory affairs by leading global strategies, managing submissions, and guiding cross-functional teams in a fast-paced biotech environment. Drive impactful decisions that en...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Grow your career with a pivotal role ensuring regulatory compliance and strategic oversight for FDA submissions, while leading integrated project teams and driving innovative approaches to risk manage...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$200K - $225K *

Create and implement strategic regulatory initiatives for global drug development in a dynamic team environment, ensuring compliance and effective cross-functional collaboration within the biotechnolo...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$88K - $105K *

Join a dedicated team ensuring regulatory compliance for products in the China market. Collaborate cross-functionally to support submissions and maintain clearances, while driving projects toward time...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Champion regulatory excellence by managing lifecycle activities for non-medicinal products. Collaborate with cross-functional teams to ensure compliance, enhance product performance, and deliver effec...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

Frequently Asked Questions (FAQ)

  • What does a Senior Regulatory Affairs Specialist do?question toggle

    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?question toggle

    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?question toggle

    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?question toggle

    Progression can be achieved through continuous learning, keeping abreast of changes in regulations, obtaining relevant certifications, and gaining experience in various regulatory affairs roles.