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Regulatory Consultant Cro Jobs (NOW HIRING)

Socket.dev

Regulatory Affairs Consultant

Manhattan, NY · On-site

$89 - $134/hr

... CRO can bring? Our team says it's the best of both worlds.... ClinChoice is searching for an ... Regulatory Affairs Consultant Hybrid for 3 months Contract to join one of our clients. This ...

BeiGene USA

Senior Manager, Regulatory Affairs

$139K - $184K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Work with external regulatory consultants/CRO's as required Qualifications: * 7+ years' related experience with a BA/BS degree is required * Experience and knowledge in preparation of INDs (required ...

New

BeiGene, Inc.

Associate Manager, US Regulatory Affairs

$103K - $138K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Work with external regulatory consultants/CRO's as required Qualifications: • BA / BS in Health Science, preferred, with at least 4+ years' experience in the pharmaceutical industry • Experience ...

BeiGene USA

Associate Manager, US Regulatory Affairs

$103K - $138K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Work with external regulatory consultants/CRO's as required Qualifications: BA / BS in Health Science, preferred, with at least 4+ years' experience in the pharmaceutical industry Experience and ...

Argenta

Senior Regulatory Affairs Manager

Shawnee, KS · On-site

Argenta is currently looking to fill the role of Senior Regulatory Affairs Manager within our CRO ... Identify and pursue new regulatory consulting opportunities which may include meeting with new ...

Argenta

Senior Regulatory Affairs Manager

Shawnee, KS · Remote

Argenta is currently looking to fill the role of Senior Regulatory Affairs Manager within our CRO ... Identify and pursue new regulatory consulting opportunities which may include meeting with new ...

Argenta

Senior Regulatory Affairs Manager

Shawnee, KS · Remote

Argenta is currently looking to fill the role of Senior Regulatory Affairs Manager within our CRO ... Identify and pursue new regulatory consulting opportunities which may include meeting with new ...

Katalyst CRO

CSV Engineer

Redwood City, CA · On-site

... Consultant to support multiple ongoing projects within a pharmaceutical environment. The ideal ... Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions ...

synergy

New Business Development Manager

Dallas, TX · Remote

  • Medical

  • Dental

  • Vision

  • PTO

... Consulting Organization (CRO) supporting pharmaceutical, biotechnology, and medical device ... Build relationships with R&D, CMC, Quality, and Regulatory leaders within target organizations.

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Regulatory Consultant Cro information

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How much do regulatory consultant cro jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for regulatory consultant cro in the United States is $50.06, according to ZipRecruiter salary data. Most workers in this role earn between $34.86 and $51.92 per hour, depending on experience, location, and employer.

What is the difference between Regulatory Consultant Cro vs Regulatory Affairs Specialist?

AspectRegulatory Consultant CroRegulatory Affairs Specialist
Required CredentialsBachelor's degree, certifications like RAC often preferredBachelor's or master's degree in life sciences, certifications like RAC common
Work EnvironmentConsulting firms, pharmaceutical or biotech companies, regulatory agenciesPharmaceutical, biotech companies, or medical device firms
Employer & Industry UsageUsed by consulting firms and contract research organizationsUsed internally within companies to manage regulatory submissions
Common Search & ComparisonOften compared for regulatory compliance rolesCompared for internal regulatory process roles

The Regulatory Consultant Cro and Regulatory Affairs Specialist roles share similar credentials and industry environments but differ mainly in their work setting. Regulatory Consultants typically work for consulting firms advising multiple clients, while Regulatory Affairs Specialists are employed internally within companies to handle regulatory submissions and compliance. Both roles require relevant certifications and industry experience, but their focus and work context distinguish them.

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Regulatory Consultant Cro jobs near you
Infographic showing various Regulatory Consultant Cro job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 86% Full Time, 9% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $104,126 per year, or $50.1 per hour.

Regulatory Affairs Consultant / Senior Consultant - Clinical Regulatory Affairs

Parexel

Remote

Full-time

Re-posted 26 days ago

Parexel rating

8.2

Company rating: 8.2 out of 10

Based on 13 frontline employees who took The Breakroom Quiz

30th of 74 rated research

Job description

When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
At Parexel, we are driven by a single purpose: to partner with our clients and help patients gain access to life-changing therapies faster.
We are currently seeking a Regulatory Affairs Consultant/ Senior Consultant to join a dedicated client partnership. In this role, you'll play a critical part in advancing innovative therapies by guiding complex global clinical development programs through the regulatory landscape with strategy, insight, and collaboration.
As a Regulatory Affairs Consultant, you will serve as a trusted regulatory leader supporting a major pharmaceutical client's clinical portfolio. This highly visible role combines regulatory strategy, global project leadership, health authority engagement, and cross-functional collaboration across programs ranging from early clinical development through registration planning and lifecycle management.
This position focuses on health authority interactions, submission planning, compliance oversight, and some regulatory strategy input-not site-level study coordination or patient-facing activities.
What You'll Do
  • Execute global regulatory strategies that support clinical development and long-term registration objectives.
  • Lead and coordinate regulatory activities across U.S., EU and international clinical trials, including large, multinational studies spanning multiple regions and regulatory jurisdictions.
  • Serve as the regulatory lead within cross-functional teams, partnering with Clinical Development, Medical Writing, Biostatistics, Quality, CROs, vendors, and external stakeholders to drive program success.
  • Manage and support regulatory submissions and maintenance activities, including IND applications, annual reports, safety submissions, CTA-related activities, protocol amendments, informed consent updates, and end-of-trial deliverables.
  • Provide strategic support for health authority interactions, including preparation of meeting requests, briefing packages, regulatory intelligence assessments, and responses to agency questions.
  • Contribute to key development and registration initiatives by supporting NDA/MAA/BLA readiness activities, reviewing clinical documentation packages, and ensuring alignment of regulatory strategy across programs.
  • Author and review regulatory documentation as needed, while partnering with dedicated authoring teams on major submission content.
  • Conduct regulatory impact assessments, identify risks, and develop proactive mitigation strategies to keep programs on track.
  • Facilitate issue resolution across multidisciplinary teams and build alignment among stakeholders to address challenges before they become barriers to success.
  • Ensure compliance with FDA, EMA, HC regulations, ICH guidelines, and applicable global regulatory requirements.

Required Qualifications
  • Minimum 5+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or CRO industry.
  • Demonstrated expertise in regulatory strategy, health authority engagement, and regulatory submissions.
  • Strong knowledge of clinical development regulations, FDA & EMA requirements, ICH guidelines, and global regulatory pathways.
  • Experience supporting IND/CTAs applications, annual reports, safety submissions, and related clinical regulatory activities.
  • Experience preparing or supporting health authority meetings and regulatory communications.
  • Understanding of global clinical trial applications and regulatory requirements across multiple regions.
  • Familiarity with electronic submission systems and regulatory publishing processes.
  • Ability to independently manage complex regulatory projects while influencing cross-functional teams and stakeholders.
  • Strong written, verbal, analytical, and problem-solving skills.
  • Bachelor's degree in a scientific or technical discipline required; advanced degree strongly preferred.
  • Experience with FDA, EMA and other major market regulations and meeting packages required.
  • Experience working with international health authorities and global regulatory submissions strongly preferred.

Preferred Qualifications
  • Experience supporting large global clinical trials and coordinating regulatory activities across multiple countries.
  • Background in oncology, immunology, immuno-oncology, or other complex therapeutic areas.
  • Project Management Professional (PMP) certification or comparable project management experience.
  • Demonstrated success managing multiple priorities, timelines, budgets, and stakeholder groups in a fast-paced development environment.

Why This Role
  • Be a strategic regulatory partner for a major pharmaceutical client with direct visibility to senior regulatory and clinical leadership.
  • Influence development programs from early clinical stages through registration planning and lifecycle management.
  • Lead global regulatory activities for innovative studies, including complex multinational trials.
  • Partner with cross-functional experts and contribute to high-impact health authority interactions and submission strategies.
  • Join a trusted, long-term client partnership where your expertise will shape program decisions and drive meaningful outcomes for patients around the world.

If you're passionate about regulatory strategy, thrive in collaborative environments, and want to make a meaningful impact on the development of innovative therapies, we'd love to hear from you.
#LI-LB1
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

What Parexel employees say

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About PAREXEL

Sourced by ZipRecruiter

Bring your Data Management expertise to Parexel's Strategic Partnerships. Although we work globally, each partnership we form is deeply personal. We are as dedicated to every aspect of our client's product development as they are - and work closely with client teams in true partnership to understand both challenges and opportunities. At Parexel we are focused on meeting customer and patient needs through collaborative partnership so that we get treatments into the hands of patients who need them most.

Industry

Pharmaceutical and medicine manufacturing

Company size

10,000+ Employees

Headquarters location

Waltham, MA, US

Year founded

1983

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