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Ora

Regulatory Writer I

Regulatory Writer I DEPARTMENT: Regulatory Ora Values the Daily Practice of... Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future ...

Ora

MA · On-site

Regulatory Writer I DEPARTMENT: Regulatory Ora Values the Daily Practice of... Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future ...

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How much do regulatory writer jobs pay per hour?

As of Aug 5, 2026, the average hourly pay for regulatory writer in the United States is $38.94, according to ZipRecruiter salary data. Most workers in this role earn between $28.85 and $47.12 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a regulatory writer, and why are they important?

To thrive as a Regulatory Writer, you need a solid background in life sciences or pharmacy, excellent writing skills, and a thorough understanding of regulatory guidelines. Familiarity with document management systems, medical writing software, and knowledge of ICH, FDA, and EMA requirements are typically required. Attention to detail, strong organizational skills, and the ability to communicate complex information clearly set outstanding candidates apart. These competencies ensure accurate, compliant, and timely documentation crucial for successful regulatory submissions in the pharmaceutical and biotech industries.

What is the difference between Regulatory Writer vs Medical Writer?

AspectRegulatory WriterMedical Writer
CredentialsTypically requires life sciences degree, regulatory affairs certificationsOften requires life sciences degree, medical or scientific writing experience
Work EnvironmentPharmaceutical, biotech, or medical device companies, regulatory agenciesPharmaceutical, healthcare, or academic research settings
Industry UsageUsed for preparing regulatory submission documentsUsed for scientific publications, clinical study reports

Regulatory Writers focus on creating documents for regulatory submissions, ensuring compliance with industry standards. Medical Writers produce scientific content for publications, clinical reports, and educational materials. While both roles require scientific expertise, Regulatory Writers specialize in regulatory documentation, whereas Medical Writers focus on scientific communication and publication.

What is a regulatory writer?

Regulatory writers are professionals who prepare documents required for the approval, registration, and maintenance of pharmaceutical, biotechnology, or medical device products. They create clear, accurate materials such as clinical study reports, regulatory submissions, and summaries for agencies like the FDA or EMA. These writers ensure that documents comply with regulatory guidelines and help communicate complex scientific information in an understandable way. Their work is crucial for bringing new medical products to market and maintaining compliance throughout a product’s lifecycle.

How much does a regulatory writer make?

A regulatory writer typically earns between $60,000 and $100,000 annually, depending on experience, industry, and location. Senior regulatory writers or those with specialized knowledge in areas like pharmaceuticals or healthcare may earn higher salaries, often supplemented by certifications and strong technical writing skills.

What are some typical challenges faced by regulatory writers when preparing submission documents?

Regulatory Writers often encounter challenges such as interpreting complex scientific data and ensuring it meets stringent regulatory guidelines. They must coordinate input from multidisciplinary teams, manage tight timelines, and adapt to evolving regulations across different regions. Effective communication and attention to detail are crucial, as even minor inconsistencies can delay regulatory approvals. Collaboration with subject matter experts and project managers is a key part of the process to ensure accuracy and compliance.
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Regulatory Writer jobs near you
Infographic showing various Regulatory Writer job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 86% Full Time, 10% Part Time, and 3% Contract. Highlights an 91% Physical, 4% Hybrid, and 5% Remote job distribution, with an average salary of $81,001 per year, or $38.9 per hour.

Regulatory Writer I

Ora

Remote

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 11 days ago

Job description

POSITION TITLE: Regulatory Writer I
DEPARTMENT: Regulatory
Ora Values the Daily Practice of...
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 400 employees across North America, Europe, Asia, and Latin America.
The Role:
Our Regulatory Writer I is responsible for researching, writing, and editing materials for regulatory submission to the FDA from pre-clinical to clinical trials Phase 1 - 4. This is an individual contributor working on a team as an active partner in regulatory project planning and execution reporting to the Manager of Regulatory. Ora's Regulatory Writer I will work collaboratively with our Clinical Project Managers, Clinical Trial Associates (CTA) and cross-functional departments such as Clinical Operations, Quality Assurance, Operations and Chemical Manufacturing Control (CMC). The Regulatory Writer I will identify and execute the timeline plans for clinical, nonclinical, and CMC by way of coordinating, authoring, and developing domestic and international drug applications and submissions in support of clinical programs within the US and globally. This role offers high visibility and exposure to working with the FDA regulatory requirements, Good Clinical Practice (GCP), ICH guidelines, and/or eCTD format.
What You'll Do:
  • Author and compile FDA and Ex-US regulatory applications and submissions, inclusive of general correspondence, INDs, CTAs, protocol and information amendments, annual reports, Safety reports, meeting briefing documents, PSPs, and NDAs/MAAs, as well as peer-reviewed manuscripts, slide decks, and posters with oversight and assistance as needed.
  • Assist in the research of scientific and regulatory information in order to write submission documents.
  • Work with data management and clinical teams, as well as sponsors and KOLs to review protocol development and interpret clinical trial data for CSRs
  • Responsible for contributing to the development of project timelines and the planning of regulatory milestones and tracking of commitments.
  • Responsible for communication of commitments to team members.
  • Lead multiple, concurrent projects, with support from the Principal or Regulatory Manager
  • Format and edit regulatory documentation for inclusion in INDs, CTAs, and other global submissions.
  • Support on-time preparation and publication of regulatory submission documents in coordination with the Regulatory Operations function
  • Perform other appropriate administrative duties, such as preparing correspondence (records of contact), filing, quality management system support, where necessary.
  • Maintain chronological and operational trackers as needed.
  • Assist other writers in the compilation, writing, and editing of regulatory, scientific manuscript, marketing deliverables, and trade journal articles.
  • Ensure quality of content and format of writing projects in accord with applicable regulations, guidelines, and corporate SOPs
  • Adhere to all aspects of Ora's quality system.
  • Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
  • Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors.
  • Responsibilities may differ from the above based on the specific needs of the business.

What We Look For:
  • Experience needed for the Role:
    • Master's degree in applied or life science or communications
    • 1 year of medical, regulatory, or clinical writing experience or equivalent training and work experience, including coursework.
  • Additional Skills & Attributes:
    • Ability, with oversight, to write, edit, or otherwise facilitate completion of all clinical regulatory document types, including eCTD documents or similar, or protocols for Early Phase, Phase II or Phase III trials
    • Ability to analytically evaluate and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical and therapeutic teams.
    • Goal-oriented with an ability to set detailed timelines for completion of assigned projects and ensure efficient, timely completion
    • Excellent communication, interpersonal, negotiation and project management skills
    • Strong attention to detail with well-developed organization, research, and investigative skills.
    • Ability to work in an ever-changing environment; demonstrated ability to multitask and achieve deadlines and targets under time constraints
    • Strong time management skills, with the ability to work on multiple projects simultaneously
    • Ability to work well in a team environment, with the ability to work effectively independently
    • Multi-lingual communication is a plus
  • Competencies and Personal Traits:
    • What We Do:
        • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
    • How We Do It:
        • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
        • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
    • Why We Do It:
        • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

What We Offer:
  • Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
  • Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
  • Financial: Competitive salaries along with a 401K plan through Fidelity with company match.
  • Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
  • Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure.
  • Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
  • Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.
  • Career Development Opportunities:Continued opportunities to grow and develop your career journey.
  • Global Team: Opportunities to work with colleagues across the globe.
  • Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.
Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good - to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.
We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Our Privacy Policy | Ora (oraclinical.com)

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