Senior Regulatory Affairs Specialist

2 weeks ago


San Rafael, California, United States Tucker Parker Smith Group (TPS Group) Full time

Regulatory Affairs Manager – Clinical & Nonclinical Submissions

Location:
Fully Remote

Industry:
Biotechnology / Pharmaceutical

Duration:
10 months (potential to extend or convert)

Pay:
$60-70/hour

Our client is a leading biotechnology company known for developing breakthroughs in rare and specialty diseases. They combine cutting-edge science with a mission-driven culture, offering an environment where regulatory professionals can directly impact meaningful, life-changing therapies. This is an exciting chance to join a passionate team working at the forefront of global drug development.

About the Role

Our client, an innovative biotechnology company, is seeking a
Regulatory Affairs Manager
to support global nonclinical and clinical regulatory activities. This role helps drive regulatory strategy, supports Health Authority interactions, and contributes to key submissions across the product lifecycle.

What You'll Do

  • Support development of nonclinical/clinical regulatory strategy.
  • Assist with planning and preparing for Health Authority (HA) meetings.
  • Participate in cross-functional study and program teams.
  • Contribute to IND/CTA updates, annual reports, protocols, and briefing documents.
  • Coordinate and review regulatory submission content (INDs, CTAs, NDAs, BLAs).
  • Partner with Regulatory Operations and Project Management on timelines and deliverables.
  • Maintain and organize regulatory documentation and archived submissions.
  • Support updates to core dossiers for international markets and lifecycle submissions.

What We're Looking For

  • Degree in a scientific discipline (e.g., life sciences, chemistry, molecular biology).
  • PhD preferred; MS/BS with strong relevant experience also considered.
  • 4+ years of Regulatory Affairs experience
    , ideally within nonclinical and/or clinical development.
  • Experience supporting global submissions and Health Authority interactions strongly preferred.
  • Excellent communication, organizational, and cross-functional collaboration skills.
  • Ability to manage multiple priorities and deliver high-quality work in a fast-paced environment.


  • San Diego, California, United States Surf Search Full time

    We are looking for a talented Senior or Principal Regulatory Affairs Specialist to join our client's team and play a crucial role in bringing new products to market. This role will be responsible for leading the regulatory strategy and managing submissions for new product launches for our client's cardiovascular medical device portfolio.This hands-on role...


  • San Diego, California, United States Immorta Bio Full time

    Company DescriptionImmorta Bio, Inc. is a regenerative medicine company focused on developing patient-specific therapeutic solutions to address diseases of aging and aging as a disease. Our innovative work revolves around personalized stem cell technologies with the potential to revolutionize treatments for age-related conditions. At Immorta Bio, we aim to...


  • San Diego, California, United States GRIFOLS, S.A. Full time $105,800 - $132,250

    table.MiTabla { max-width: 1020px;importantWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived...


  • South San Francisco, California, United States Maze Therapeutics Full time $180,000 - $220,000

    The Position: Join Maze Therapeutics as a Senior Manager, Regulatory Affairs, where you will play a critical role in advancing our clinical-stage programs by providing regulatory expertise and executional leadership. As a key member of the development team, you will collaborate with cross-functional teams to manage and support global regulatory activities....


  • San Francisco, California, United States Compass Regulatory Full time

    Compass Reg supports leading agriculture companies to simplify their regulatory work, helping them bring new products to the farmers who need them.We tackle regulatory challenges in a unique way, leveraging a modern software platform that increases automation, security, and organization of regulatory workplusa team of deep regulatory experts who support our...


  • San Diego, California, United States Dexcom Full time

    The CompanyDexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting...


  • San Diego, California, United States Insmed Incorporated Full time

    At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful...


  • San Francisco, California, United States PROCEPT BioRobotics Full time

    Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in...


  • San Diego, California, United States DexCom Full time

    The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting...


  • San Francisco, California, United States Pano AI Full time $165,000 - $200,000

    Who we areThe problem: Every minute matters in fire response.  As climate change amplifies the intensity of wildfires—with longer fire seasons, drier fuels, and faster winds—new ignitions spread faster and put more communities at risk. Today, most wildfires are detected by bystanders and reported via 911, meaning it can take hours to detect a fire,...