---
title: 'Regulatory Manager at Precision for Medicine'
canonical: 'https://feeny.ai/job/regulatory-manager-precision-for-medicine-united-states-kqsnd1sy9gwt'
type: 'job'
last_seen: '2026-09-14'
---

# Regulatory Manager at Precision for Medicine

- **Company:** Precision for Medicine
- **Location:** United States
- **Compensation:** $106k–$151k
- **Work type:** remote
- **Posted:** 2026-08-18
- **Last confirmed live:** 2026-09-14
- **Apply:** https://job-boards.greenhouse.io/pfm/jobs/6146290004

## Job description

Position Summary:

The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.

Essential functions of the job include but are not limited to:

- Provides regulatory guidance throughout the clinical development life cycle
- Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications. Also provides strategic regulatory input as required.
- Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
- Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
- Works within a project team, and where necessary, leads project for the region or globally
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
- Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
- Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
- Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
- Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
- Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
- Provides ICH GCP guidance, advice and training to internal and external clients
- Serve as representative of Global Regulatory Affairs at business development meetings

Qualifications:

Minimum Required:

- Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
- Computer literacy (MS Office/ Office 365)
- Fluent in English

Preferred:

- Graduate, postgraduate
- Possesses basic understanding of financial management

Other Required:

- 5 + years or more relevant regulatory affairs experience
- Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
- Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
- Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
- Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
- Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
- Availability for domestic and international travel including overnight stays

Competencies

- Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities
- Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates
- Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
- Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment
- Motivates other members of the project team to meet timelines and project goals
- Flexible attitude with respect to work assignments, and new learning
- Resolves project related problems and prioritize workload to meet deadlines with little support from management
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
- Collects data of consistently high standard
- Communicates both verbally and in written form in an acceptable manner
- Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency

#LI-Remote

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $106,000—$151,000 USD

Any data provided as a part of this application will be stored in accordance with our [Privacy Policy.](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&reserved=0) For CA applicants, please also refer to our [CA Privacy Notice](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&reserved=0).

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.

## About Precision for Medicine

## Company Overview
- **One-liner**: Precision for Medicine is a global clinical research organization (CRO) and laboratory services provider specialized in accelerating the development of precision therapies for oncology, rare disease, and other complex conditions.
- **Entity Type**: Private – subsidiary of Precision Medicine Group (a private holding company)
- **Headquarters**: Not explicitly stated in sources; likely around the Washington D.C./Maryland area (Precision Medicine Group HQ is in Bethesda, MD). The company operates globally with labs in North America and Europe.
- **Founded**: 2012 (company began), but the team has over 25 years of clinical trial experience
- **Founders**: Not publicly disclosed on provided sources; leadership includes a founder role but name not given.

## Core Business
- **Primary industries**: Contract Research Organization (CRO) services, central laboratory services, biospecimen solutions, data intelligence for clinical development.
- **Target customers**: Biotechnology and pharmaceutical companies developing precision medicines, especially in oncology and rare disease (B2B, mid-to-large pharma).
- **Mission/purpose**: “Bringing life-changing therapies to patients by integrating laboratory expertise, clinical trial excellence, and data intelligence to deliver critical insights into patient biology.”

## Products & Services
- **Global CRO Services**: Full-service clinical trial management with a focus on early- and late-phase development, regulatory support, project management, and site startup. Over 75% of trials are in oncology.
- **Global Laboratory Services**: Translational and biomarker sciences, including specialty labs for genomics, flow cytometry, molecular diagnostics, and central lab testing. Operates 5 specialty labs in the US and Europe.
- **Biospecimens**: Access to over 11 million tissue, cellular, and biofluid specimens for research.
- **Data Intelligence**: AI-enabled data ecosystem for sample management, biomarker analysis, biostatistics, and decision support (includes a conversational AI virtual assistant).
- **Diagnostics and Companion Diagnostics (CDx)**: Development and commercialization of diagnostic tests aligned with therapies.

## Market Standing
- **Valuation / Market Cap**: Not publicly disclosed (part of private Precision Medicine Group).
- **Key Metric**: ~3,500 employees; 2,500+ clinical trial and lab projects; 70% of clinical trials in oncology; 25+ years of combined experience.
- **Notable Investors/Partners**: Sources mention “$30B in investments raised for biotech in the last 5 years” (general biotech investment, not specific to Precision). No specific lead investors listed; backed by private equity (Precision Medicine Group is owned by institutional investors).
- **Growth Signals**: Awarded the 2025 Fierce Biotech CRO Award for Innovative Solutions in Drug Development. Active hiring with 129 job openings globally (as of July 2026). Strong remote/hybrid work options across many roles.

## Competitive Advantages
- **Integrated CRO + Lab + Data**: One organization covering the full spectrum from biospecimens to late-phase trials, reducing inefficiencies of working with separate vendors.
- **Specialization in complex indications**: Deep expertise in oncology and rare disease, where protocols are highly complex.
- **Right-sized CRO model**: Assigns employees to no more than 2–3 trials at a time, offering more attention than large “Big Five” CROs (positioned as “antidote to Big Five Fatigue”).
- **AI-enabled data intelligence**: Unified ecosystem with conversational AI to extract insights from siloed data.

## Strategic Focus
- Continue expanding capabilities in precision medicine development, particularly in early-phase oncology and rare disease.
- Leverage data intelligence and AI to improve trial efficiency and patient matching.
- Scale global clinical operations (recent push into Asia Pacific, Latin America, and Eastern Europe).

## Why Work Here
- **Culture**: Employee-driven mission “to help patients get access to innovative treatments.” Collaboration across functions is emphasized, with a focus on complex and impactful therapies.
- **Work environment**: Strong remote/hybrid options – job postings span remote roles in the US, Canada, Europe, Asia, and Latin America. Offices and labs exist in multiple countries.
- **Perks & growth**: Not explicitly detailed, but the company invests in career development (e.g., roles from CRA to Director level). 25 years of history and a growing global footprint indicate stability and upward mobility.
- **Engineering & science culture**: Teams include clinical scientists, data engineers, lab professionals, and operations – a blend of deep science and tech.

## Sources
1. [Precision for Medicine – Homepage](https://www.precisionformedicine.com/)
2. [Precision for Medicine – Our Story](https://www.precisionformedicine.com/about-us/our-passion/)
3. [Precision for Medicine – Leadership](https://www.precisionformedicine.com/about/leadership)
4. [Precision for Medicine – Careers (Greenhouse)](http://job-boards.greenhouse.io/pfm)
5. [Precision for Medicine – LinkedIn](https://www.linkedin.com/company/precision-for-medicine)

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