Regulatory Operations Manager

Job Title: Regulatory Operations ManagerJob Description

The Regulatory Operations Manager leads the development, implementation, and oversight of the organization's regulatory operations program across cosmetics, OTC pharmaceuticals, and medical devices. This role ensures that all product and establishment registrations, listings, and licenses remain current and compliant with applicable regulations, including MoCRA and FDA requirements. The position also manages regulatory and compliance support for customers, collaborates closely with internal stakeholders to maintain and improve the quality system, and proactively monitors the regulatory landscape to identify and address compliance risks.

Responsibilities

• Establish and maintain a comprehensive regulatory operations program that supports cosmetics under MoCRA, OTC pharmaceutical products, medical devices, and other regulated product categories in all markets served.
• Develop, implement, and maintain procedures for handling FDA product listings for cosmetics, OTC pharmaceuticals, medical devices, and any other listings required by regulators.
• Ensure all company registrations and listings are completed accurately, submitted on time, and maintained as current, including annual FDA establishment registrations for cosmetic, OTC, and medical device operations.
• Manage and maintain FDA cosmetic product listings to ensure full compliance with MoCRA and other applicable regulations.
• Manage and maintain FDA medical device product listings, ensuring that all device information is accurate and up to date.
• Manage and maintain FDA OTC NDC product listings, including updates related to new products, changes, or discontinuations.
• Coordinate and complete FDA annual volume reporting and any other recurring regulatory submissions required by federal or state authorities.
• Ensure that all required state licenses related to cosmetic, OTC, and medical device operations are obtained, renewed, and kept current.
• Continuously monitor the regulatory landscape, including new and evolving FDA, MoCRA, ICH, and GMP requirements, and provide site management with timely regulatory assessments.
• Communicate compliance risks clearly and promptly to site management and relevant stakeholders, and develop action plans to address any regulatory changes that impact the quality system.
• Collaborate with quality and operational teams to integrate new regulatory requirements into existing procedures and quality system documentation.
• Establish and maintain a structured process for managing customer regulatory and compliance-related tasks, ensuring consistent and timely support.
• Manage customer regulatory and compliance requests, including assisting customers in the completion of documentation that supports global product registrations.
• Provide CDMO-related documentation and supporting materials to customers to facilitate global product registrations and regulatory submissions.
• Review, negotiate, and complete Quality Agreements with customers, ensuring a consistent and compliant approach across all agreements.
• Support the advancement and continuous improvement of the quality system by participating in quality initiatives and performing other quality-related duties as assigned.
• Work collaboratively in a fast-paced environment to identify, propose, and implement process improvements that enhance regulatory compliance and operational efficiency.
• Prepare clear, concise written communications, reports, and regulatory documentation for internal and external stakeholders.

Essential Skills

• BA/BS degree in a relevant scientific or technical discipline, preferably in science, engineering, or biological sciences.
• 3-8 years of experience working in a cGMP environment and related quality or regulatory field.
• Demonstrated expertise in regulatory affairs and regulatory compliance for cosmetics, OTC pharmaceuticals, and/or medical devices.
• Strong knowledge of FDA regulations and procedures, including FDA 21 CFR 210, 211, and 21 CFR 820.
• Familiarity with MoCRA legislation and its impact on cosmetic product listings and regulatory obligations.
• Experience with OTC products and related FDA requirements, including NDC listings.
• Solid understanding of relevant GMP regulations and ICH guidelines.
• Proven ability to operate in a cGMP-compliant environment and support quality system requirements.
• Strong focus on continuous improvement and quality, with the ability to identify and drive enhancements to processes and systems.
• Excellent interpersonal and communication skills, with the ability to write in a clear, concise manner for regulatory and quality documentation.
• Ability to work effectively in a fast-paced environment and collaborate with cross-functional teams.

Additional Skills & Qualifications

• Certification such as Certified Quality Auditor or a Regulatory Affairs Certificate is preferred.
• Prior experience supporting global product registrations for cosmetics, OTC, or medical devices.
• Experience managing FDA establishment registrations, product listings, and annual volume reporting.
• Experience reviewing and completing Quality Agreements with customers or partners.
• Demonstrated ability to manage multiple regulatory projects and deadlines simultaneously.
• Strong organizational skills and attention to detail in preparing and maintaining regulatory documentation.
• Ability to interpret, summarize, and communicate changes in regulatory requirements to non-specialist stakeholders.
• Comfort working in a contract development and manufacturing (CDMO) context, supporting external customer needs.

Work Environment

The role operates in a regulated, cGMP-compliant environment that supports cosmetic, OTC pharmaceutical, and medical device activities. You will collaborate closely with quality, operations, and customer-facing teams in a fast-paced setting that emphasizes accuracy, documentation integrity, and continuous improvement. Work involves frequent interaction with regulatory databases and electronic systems for FDA listings, reporting, and documentation management. The culture values teamwork, clear communication, and a proactive approach to identifying and implementing process improvements that strengthen compliance and the overall quality system.

Job Type & Location

This is a Permanent position based out of Harleysville, PA.

Pay and Benefits

The pay range for this position is $105000.00 - $115000.00/yr.

Medical, dental, and vision insurance coverage effective the first of the month after 30 days of employment Flexible Spending Account (FSA) or Health Savings Account (HSA) Company-paid life insurance, short term disability, long term disability 401(k) program with a 50% match on the first 8% contributed, available after one month of service Pet insurance via Pet Benefit Solutions Accrue 120 hours of paid time off (PTO) annually. PTO is inclusive of sick, vacation, and personal time and will be pro-rated based on your start date. Ten (10) company-paid holidays Spousal Coverage Eligibility: If your spouse has access to medical, prescription, dental, or vision coverage through their own employer, they are not eligible to enroll in Accupac's benefit plans. Exceptions apply if your spouse lacks employer-sponsored coverage, in which case a Spousal Coverage Certification is required.

Workplace Type

This is a fully onsite position in Harleysville,PA.

Application Deadline

This position is anticipated to close on Aug 7, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.