Senior Manager, Regulatory Compliance & International Regulatory Affairs

Prestige Brands•Lynchburg, VA

7d•$110,000•Onsite

About The Position

Develops and administers activities to register drugs, cosmetics, dietary supplements, devices, and other products internationally, while maintaining regulatory compliance for the manufacturing facility and its products. Leads regulatory strategy for assigned regions and actively partners in project planning and execution. Interprets regulations, guidelines, and compliance requirements and communicates them across the company. Serves as a regulatory representative and leader on multidisciplinary teams and document reviews, advising on international regulatory activities such as claims support, specifications, labeling, regulatory submissions, and documentation, as well as site-related issues. Determines registration requirements and manages preparation and submission of documentation for product registration, compliance, and maintenance. Communicates requirements and recommends strategies throughout the organization, including to executive management. The position is based at Fleet Laboratories’ Lynchburg, Virginia location, in a clean, air-conditioned cGMP environment. Fleet Laboratories describes itself as a global producer of more than 100 personal health and beauty products and emphasizes its long-standing presence in the Lynchburg community.

Requirements

BA/BS degree in a scientific or legal field.
At least nine years of regulatory experience.
At least three years of experience managing direct reports.
Applicants must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice To Haves

Regulatory experience in the OTC drug, cosmetic, or dietary supplement industry is preferred.

Responsibilities

Lead development and implementation of international regulatory strategy for assigned products and regions, and aid strategy development and implementation for other regions.
Help departments interpret and comply with international product registration regulations.
Represent Regulatory Affairs on multidisciplinary teams and interpret requirements for OTC drugs, cosmetics, dietary supplements, and other products.
Maintain current knowledge of data requirements, SOPs, policies, regulations, guidelines, and industry standards, including ICH, WHO, GMP, GCP, stability, validation, and FDA and EU regulations.
Review and approve product labels, inserts, advertisements and commercials, journal articles, websites, and other materials as needed.
Review and approve change control forms, batch records, specifications, stability reports, and other quality-related documentation for products made on site.
Manage direct reports and provide leadership and mentorship to other regulatory personnel.
Draft and/or review departmental policies and procedures.
Provide relevant training to employees throughout the organization as appropriate.
Assist Legal with FCPA/OFAC screening of foreign distributors and other foreign business partners.
Communicate effectively in writing and orally, including editing documents prepared by others.
Identify issues and improvement opportunities, and suggest and implement solutions.
Communicate with foreign regulatory agencies, distributors, consultants, and industry groups as required.
Determine regulatory and registration requirements and manage assembly, compilation, and submission of documentation for product registration, compliance, and maintenance.
Communicate regulatory requirements and recommend execution pathways and strategies to all organizational levels, including executive management.
Perform other related duties as needed.