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Regulatory Writing Jobs (NOW HIRING)

Synterex

Manager, FSP Medical Writing

Boston, MA · Remote

Comply with international, national, and pertinent local regulations * Adhere to SOPs and guidance ... Support Medical Writing and Business Development leadership in preparation of work orders, budgets ...

Synterex

Manager, FSP Medical Writing

Boston, MA · Remote

Comply with international, national, and pertinent local regulations * Adhere to SOPs and guidance ... Support Medical Writing and Business Development leadership in preparation of work orders, budgets ...

Synterex

Manager, FSP Medical Writing

Boston, MA · On-site

$16K/mo

Comply with international, national, and pertinent local regulations * Adhere to SOPs and guidance ... Support Medical Writing and Business Development leadership in preparation of work orders, budgets ...

SQUAXIN ISLAND TRIBE

Regulatory Agent

Shelton, WA · On-site

Regulatory Agent Department: Gaming Reports To: TGA Manager FLSA Status: Non-Exempt Time Status ... Write detailed, accurate, and thorough Incident Reports on all incidents that occur on the property ...

MMS

Senior Medical Writer (Remote)

Canton, MI · On-site

Highly proficient with styles of writing for various regulatory documents * Expert proficiency with client templates & style guides * Interact directly and independently with client to coordinate all ...

MMS Holdings Inc.

Nonclinical Writer

Canton, MI · On-site

Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory ...

MMS

Nonclinical Writer

Boston, MA · On-site

Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory ...

MMS

Nonclinical Writer

Canton, MI · On-site

Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory ...

Prometrika LLC

Senior Medical Writer

Cambridge, MA · On-site

$134K - $162K/yr

Minimum of 6 years of experience in medical writing with a minimum 4 years regulatory writing in biotechnology/pharmaceutical industry SKILLS * Knowledge of ICH recommended content of Investigator ...

Olema Oncology

Lead Senior Medical Writer

Boston, MA · On-site +1

$160K - $175K/yr

In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones. This ...

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Regulatory Writing information

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$15

$34

$145

How much do regulatory writing jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for regulatory writing in the United States is $34.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $26.20 per hour, depending on experience, location, and employer.

What are some common challenges faced by Regulatory Writers in the industry?

Regulatory Writers often face tight deadlines and the need to manage complex, highly detailed documents that must comply with evolving regulatory requirements. They regularly coordinate input from diverse teams such as clinical, safety, and regulatory affairs, which can pose communication and alignment challenges. Staying current with changing international regulations and ensuring absolute accuracy in submissions are other common demands. However, these challenges also make the work engaging and offer opportunities to continuously learn and develop expertise in both scientific communication and regulatory affairs.

What are the key skills and qualifications needed to thrive in the Regulatory Writing position, and why are they important?

To thrive in Regulatory Writing, you need expertise in scientific or medical writing, an understanding of regulatory guidelines (such as FDA, EMA, or ICH), and typically a background in life sciences or related fields. Competence with document management systems, referencing tools like EndNote, and familiarity with submission platforms are often required. Strong organizational skills, attention to detail, and the ability to collaborate across multidisciplinary teams are key soft skills. These skills ensure the creation of accurate, compliant, and clear regulatory documents critical for drug and device approval processes.

What is a Regulatory Writing job?

A Regulatory Writing job involves creating and reviewing documents required for regulatory submissions in industries like pharmaceuticals, biotechnology, and medical devices. Regulatory writers ensure that documents comply with guidelines from regulatory agencies such as the FDA or EMA. Their work includes clinical study reports, investigator brochures, and regulatory submission dossiers. Strong writing skills, scientific knowledge, and attention to detail are essential for this role.

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Regulatory Writing jobs near you
Infographic showing various Regulatory Writing job openings in the United States as of May 2026, with employment types broken down into 1% As Needed, 75% Full Time, 22% Part Time, and 2% Contract. Highlights an 83% Physical, 2% Hybrid, and 15% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.
Senior Director/ Director, CMC Regulatory Affairs

Senior Director/ Director, CMC Regulatory Affairs

ORIC Pharmaceuticals

South San Francisco, CA • On-site

$250K - $300K/yr

Full-time

Posted 29 days ago

Job description

Company Description
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.
Reporting to the Chief Technical Officer, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical Operations team. This position is responsible for leading CMC regulatory activities and supporting all of ORIC's clinical development programs for oncology products. The role involves close collaboration with cross-functional teams including regulatory affairs, regulatory operations, quality, CMC, nonclinical, and clinical departments.
Job Description
  • Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORIC's products.
  • Provide CMC regulatory support for new and ongoing clinical trials, e.g., manage/prepare CMC document packages in support of INDs, CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs)
  • Work collaboratively with Pharmaceutical Development, Drug Substance, and GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
  • Lead preparation and responses for CMC-related meetings with global RAs and HAs, balancing regulatory requirements and corporate objectives.
  • Maintain current awareness of relevant global CMC requirements and identify and assess global regulatory risks and mitigation plans.
  • Planning, oversight, and management of all CMC aspects of regulatory submissions, including strategy for updating existing dossiers, submission of new INDs/CTAs/NDAs/MAAs , etc.
  • Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
  • Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).

Qualifications
  • BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
  • At least 10+ years of highly relevant pharmaceutical/biotechnology experience with strong CMC background. Candidates at the Director level would be expected to have significant years of additional experience.
  • Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally solid-oral dose formulations, manufacturing, and regulatory writing.
  • Experience in addressing CMC-related regulatory queries from global health authorities.
  • Experience with all phases of pharmaceutical development and related implementation of phase-appropriate regulatory CMC requirements and strategies.
  • Demonstrated success driving drug product development and managing all aspects of CMC documentation.
  • Excellent working knowledge and understanding of applicable global regulations required - cGMP, global regulatory guidance, compendial requirements, including FDA, EMA, ICH, WHO, USP-NF.
  • Prior experience as primary author of CMC sections of M2 and M3 of IND,NDA, and IMPD.
  • Fluency with eCTD structure, differences in regional dossier requirements, and software tools commonly used to author, review, format, and approve submission documents.
  • Excellent attention to detail, and strong computer and organizational skills required.
  • Must be a strong team player who is fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
  • Must have a quality mindset and deliver results in an ethical and positive manner.
  • Flexibility and ability to work in a fast-paced, dynamic environment with limited supervision.
  • Proven ability to manage multiple tasks and associated deadlines.

Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $220,000-$270,000 for the Director level and $250,000-$300,000 for Senior Director, level candidates . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.

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