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Senior Manager Regulatory Operations!- REMOTE

Actalent • Dallas, TX • 6h ago

Job Title: Manager Regulatory Operations

REMOTE

100% Allocation

Must be willing to support West Coast Hours!

Job Description

Collaborate with the Director of Regulatory Operations to oversee global regulatory submission processes, electronic publishing, and regulatory systems management, with a particular emphasis on Regulatory Information Management (RIM) systems. Drive regulatory submission excellence, process optimization, and system innovation to ensure timely execution of regulatory filings across multiple health authorities, including FDA, EMA, Health Canada, MHRA, and other global agencies. Act as a subject matter expert in Veeva RIM, accountable for Common Technical Document (eCTD) submissions, global regulatory compliance, and document management best practices.

Responsibilities

Manage Regulatory Information Management (RIM) systems and Regulatory Publishing systems.

Lead and manage regulatory submission planning, publishing, and execution for global regulatory filings including INDs, CTAs, and future NDA/MAA submissions.

Support the regulatory operations infrastructure, including eCTD publishing, document content templates, and RIM.

Manage timelines and resources for all regulatory submissions, ensuring alignment with program goals and regulatory strategy.

Support the implementation and continuous improvement of regulatory systems and processes (e.g., RIM, Publishing).

Maintain regulatory submission archives.

Essential Skills

Bachelor's degree in life sciences or equivalent.

7+ years of experience in Regulatory Operations within the biotech or pharmaceutical industry, focused on clinical-stage programs.

Deep experience with eCTD publishing and global submission management (IND, CTA, BLA/NDA, MAA).

Strong knowledge of global regulatory requirements (FDA, EMA, ICH).

Proven experience working in a fast-paced, dynamic environment.

Excellent project management and cross-functional collaboration skills.

Proficiency with regulatory systems (e.g., Veeva RIM).

Work Environment

This position offers a remote work environment, allowing flexibility and the opportunity to collaborate with global teams.

PST time zone requires

Job Type & Location

This is a Contract position based out of Dallas, TX.

Pay and Benefits

The pay range for this position is $95.00 - $115.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Feb 12, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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