Regulatory Manager

Pharmaron; Baltimore (MD); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401(k) Retirement Plan

Generous PTO & Holidays

HSA contributions

Career development

Job summary

Pharmaron seeks an onsite Regulatory Manager in Baltimore, MD to lead regulatory operations for Phase I–IV studies. You will manage IRB submissions, TMF documentation, and trial regulatory files in a dynamic CRO setting.

You will mentor a regulatory team, ensure inspection readiness, and coordinate with Sponsors, Clinical Operations, and Quality to maintain compliance and program progress.

Qualifications

• Bachelor's degree or equivalent combination of education, training, and experience.
• 5-10 years of clinical research regulatory experience.
• Experience managing IRB submissions and approvals.
• Experience with essential documents for clinical trials.

Responsibilities

• Lead regulatory activities across the full trial lifecycle, including IRB submissions and amendments.
• Maintain regulatory binders and electronic TMF to ensure inspection-readiness.
• Support study startup regulatory documentation and sponsor interactions.
• Mentor Regulatory team members and drive performance.
• Serve as regulatory liaison with Sponsors, IRBs, Clinical Ops and QA.

Skills

Regulatory submissions

IRB submissions

TMF management

Team leadership

FDA regulations

Education

Bachelor's degree in life sciences

Tools

Veeva Vault TMF

Florence eTMF

Job description

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

Position

Regulatory Manager

Hourly Range

$80,000 - $120,000

Location

Baltimore, MD (On-site)

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

We’re proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

Pharmaron Clinical Pharmacology Center (CPC) is seeking an experienced Regulatory Manager or Senior Regulatory Manager to lead critical regulatory operations supporting Phase I through Phase IV clinical research studies. This is an exciting onsite opportunity for a regulatory professional who thrives in a fast-paced CRO environment and has deep expertise in IRB submissions, clinical trial regulatory documentation, Trial Master Files (TMF), and team leadership.

What You’ll Do

As the Regulatory Manager, you will serve as the regulatory subject matter expert and oversee regulatory activities from study startup through closeout. In this highly visible role, you will ensure regulatory compliance throughout the clinical trial lifecycle while mentoring and developing a team of regulatory professionals.

Key Responsibilities

• Lead all regulatory activities throughout the clinical trial lifecycle, including IRB submissions, protocol amendments, informed consent updates, safety reporting, and study closeout submissions.


• Manage and maintain regulatory binders and electronic Trial Master Files (eTMF), ensuring essential documents are complete, compliant, and inspection-ready.


• Oversee study startup regulatory documentation and support sponsor, audit, and inspection readiness activities.


• Lead, mentor, and develop Regulatory team members while driving departmental performance, compliance, and continuous improvement.


• Serve as the primary regulatory liaison with Sponsors, IRBs, Clinical Operations, and Quality teams to support successful study execution and regulatory compliance.

What We’re Looking For

• Bachelor's degree or equivalent combination of education, training, and experience.


• 5-10 years of clinical research regulatory experience.


• 5-10 years of hands‑on experience managing IRB submissions and approvals.


• 5-10 years of experience managing essential documents for clinical trials.


• Strong working knowledge of: ICH-GCP Guidelines


• Strong working knowledge of: FDA regulations


• Strong working knowledge of: 21 CFR Part 50 (Protection of Human Subjects)


• Strong working knowledge of: 21 CFR Part 56 (Institutional Review Boards)


• Experience with electronic Trial Master File (eTMF) systems, including:


• Veeva Vault TMF and/or


• Florence eTMF


• Excellent written and verbal communication skills.


• Strong organizational, problem-solving, and project management abilities.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions


• 401(k) Retirement Plan with generous employer matching


• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance


• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts


• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance


• Employee Assistance Program (EAP), mental health resources, and wellness programs


• Family-friendly benefits, including fertility support and maternity resources


• Professional development and career growth opportunities within a leading global CRO/CDMO

As an Equal Employment Opportunity and affirmative action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

About Pharmaron

Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

Pharmaron is proud to be an Equal Employment Opportunity and affirmative action employer.