Sr. Regulatory & Compliance Manager

Sr. Regulatory & Compliance Specialist

Direct Placement | Competitive Benefits | Offers Room for Growth

Job Description

This role is responsible for establishing, interpreting, and maintaining compliance with applicable U.S. OTC drug regulations throughout the product lifecycle. The position provides regulatory guidance across product development, manufacturing, and commercialization, ensuring product safety, efficacy, and compliance with federal, state, and local requirements, including MoCRA.

Responsibilities

• Provide regulatory guidance for the development, manufacture, and marketing of OTC human drug products.
• Stay current on regulatory requirements and guidance impacting OTC products, including MoCRA.
• Assess new and revised OTC products for regulatory compliance.
• Review and approve OTC formulations, weight sheets, and manufacturing procedures.
• Prepare, review, and approve SOPs and work instructions related to Regulatory Affairs.
• Review ADPRs and other regulatory documentation supporting product compliance.
• Develop, implement, and maintain regulatory compliance programs across departments.
• Investigate and resolve compliance issues using data-driven approaches.
• Lead Regulatory Affairs activities for internally developed products and externally developed customer products.
• Serve as a regulatory liaison with the FDA for product-related and business interactions.
• Coach and develop team members in regulatory decision-making and compliance best practices.
• Ensure regulatory procedures and documentation remain current and effective.
• Lead FDA inspections and global regulatory audits.
• Act as the primary front-room contact during regulatory inspections.
• Prepare and submit responses to regulatory inquiries and observations.
• Support customer audits and audit readiness activities.
• Coordinate internal preparation and responses related to FDA inspections.
• Maintain OTC drug and cosmetic product listings with the FDA.
• Manage ISO certification status, permits, and regulatory licenses.
• Coordinate with internal teams and customers to obtain source documentation for product listings.
• Initiate new product listings and manage changes within regulatory portals.
• Review and approve contracts with FDA submission filing agencies.
• Maintain complete and accurate documentation supporting regulatory submissions and listings.
• Develop and maintain procedures governing change control processes.
• Partner with cross-functional stakeholders to assess regulatory impact and risk.
• Ensure changes are reviewed, approved, and implemented in compliance with regulatory requirements.
• Maintain traceability and documentation within the quality system.
• Manage the OTC supplier qualification program.
• Develop and maintain supplier qualification procedures.
• Review raw material records and changes to ensure testing aligns with regulatory and customer requirements.
• Conduct supplier audits or assessments and document results within the quality system.
• Monitor approved suppliers to ensure ongoing compliance and performance standards are met.

Additional Skills & Qualifications:

• Bachelor’s degree in Chemistry, Biology, Microbiology, or a related scientific discipline, or equivalent combination of education and experience.
• Minimum of 7 years of Regulatory Affairs experience, including at least 5 years in a regulated manufacturing environment such as pharmaceuticals, OTC, cosmetics, personal care, or food processing.
• Demonstrated, current knowledge of U.S. federal, state, and international regulatory requirements impacting OTC products.
• Working knowledge of 21 CFR Parts 210 and 211 and their application within a manufacturing environment.
• Strong understanding of regulatory principles across the OTC product lifecycle, including development, manufacturing, and commercialization.
• Ability to interpret and apply regulatory requirements to real-world manufacturing and quality systems.
• Regulatory Affairs (RAC) certification or equivalent is preferred.

This is a Permanent position based out of Minneapolis, MN.

The pay range for this position is $97387.53 - $146091.98/yr.

Benefits - Health, Dental, Vision, 401K PTO - 4 weeks

This is a fully onsite position in Minneapolis,MN.

This position is anticipated to close on Apr 7, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $97,388 - $146,092