Senior Manager, Regulatory Compliance & International Regulatory AffairsDepartment: Regulatory Affairs
Location: Lynchburg, VA
Compensation: Starting at 110,000
Occupational SummaryDevelops and administers activities to register drugs, cosmetics, dietary supplements, devices and other products internationally and maintains regulatory compliance for both the manufacturing facility and its products. Leads development of regulatory strategy for assigned region(s) and is an active partner in project planning and execution.
Interprets regulations, guidelines, and compliance requirements and communicates them to other areas of the company while demonstrating a high ability to make appropriate decisions. Acts as regulatory representative and leader on multi-disciplinary teams and document reviews, providing sound advice on international regulatory activities (e.g., claims support, specifications, labeling, and the coordination and development of regulatory submissions and documentation) as well as site-related issues.
Accountabilities- Determines regulatory and registration requirements as required and manages the assembly, compilation, and submission of necessary internal and external documentation for product registration, compliance, and maintenance.
- Communicates regulatory requirements and recommends execution pathways and strategies to all levels within the organization including executive management.
Responsibilities- Leads the development and implementation of international regulatory strategy for assigned products and regions; aids the development and implementation of regulatory strategy for all other regions.
- Aids and educates all departments in interpreting and complying with international product registration regulations.
- Represents the Regulatory department on multi-disciplinary teams. Interprets regulatory requirements for OTC drugs, cosmetics, dietary supplements, and other products.
- Maintains up-to-date knowledge of data requirements, applicable SOPs, policies, regulations, guidelines, and industry standards. Knowledge areas include ICH, WHO, GMP, GCP, stability, validation, and FDA and EU regulations, among others.
- Reviews and approves product labels, inserts, advertisements/commercials, journal articles, websites, etc., as needed.
- Reviews and approves change control forms, batch records, specifications, stability reports and other quality-related documentation for products made on site.
- Manages direct report(s) and provides leadership/mentorship to other regulatory personnel. Should be recognized as a reliable and knowledgeable resource.
- Drafts and/or reviews departmental policies and procedures.
- Provides relevant training to employees throughout the organization as appropriate.
- Aids the Legal department in FCPA/OFAC screening of foreign distributors and other foreign business partners.
- Demonstrates excellent oral and written communication skills, including editing of documents prepared by others.
- Actively identifies issues or improvements, suggests and implements solutions.
- Communicates with foreign regulatory agencies, distributors, consultants, and industry groups, as required.
- Perform other related duties as needed.
Qualifications- BA/BS degree in scientific or legal field.
- Minimum of nine years' regulatory experience, preferably in the OTC drug, cosmetic or dietary supplement industry.
- Minimum of three years' experience managing direct reports.
What We OfferHere at Fleet, you can have a good job that can grow into a great career.
- The start of a great career working with a diverse group of great people.
- The health and safety of every employee... our top priority.
- A clean, air-conditioned cGMP environment.
- Top notch benefits - paid time off, 401(K) retirement savings with company match, medical, dental and vision, pay annual targeted bonus, competitive pay, life insurance, flexible spending account, and tuition reimbursement.
- Stability - a record of strong financial performance and part of a growing $1 billion company.
- A business supporting the Lynchburg community for over 150 years.
No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
