Regulatory Manager of North Americas

Company: Apex Systems
Location: Milford
Posted on: February 21, 2021

Job Description:

Regulatory ManagerPosition Summary With emphasis on over-the-counter drugs and cosmetic products for the region of North America (CAN), provides regulatory guidance and advises on regulatory requirements. Experience with EPA surface disinfectants a plus. Develops strategies for governmental approval to introduce new products to market. Manages submissions for pre-market approval. Authors internal regulatory guidelines, protocols, work instructions and standard operating procedures. Assists with the training of regulatory affairs personnel and provides direction on specific projects. Assures all governmental reporting systems and documentation comply with applicable regulatory standards and requirements for OTC drug, cosmetic, consumer and other products. Hands-on responsibilities for the support of product registrations and company licensing needs, including supervisory responsibility for one or more colleagues.Accountabilities

• Manage and implement Regulatory Affairs strategies, policies and objectives in accordance with Company strategic plans.
• Monitor and interpret changes in laws, standards and regulations; determine impact to business.
• Provide regulatory guidance, risk assessment and management throughout the product lifecycle: New Product Development and Commercial project
• Prepare submissions and reports for government agencies as required by product regulatory classification.
• Develop impact assessments and drive implementation of compliance plans.
• Review of product labels to ensure compliance with country-region specific labeling requirements.
• Manager the pre-market registration or notification process to enable product sale.
• Maintains product registration/license portfolio for applicable countries/regions, up to date.
• Participates/contributes to inspection visits by government officials or on internal audits
• Develop personnel, set performance expectations and coach to help achieve goals.
• Author or approve Regulatory and cross-functional guidelines, protocols, work instructions, SOPs.
• Support and drive process improvements.
• Participate as an effective member of cross-functional product teams.
• Build library and network of regional regulatory resources.
• Maintain specialized product category knowledge. Required Education, Skills and Experience
  • B.A. / B.S. in regulatory affairs, chemistry, engineering, or life sciences
  • 10+ years of related experience with a B.A. / B.S. degree, within over-the-counter drugs, cosmetic and/or regulated consumer products;
  • Knowledge and experience on FDA and Health Canada regulatory and applicable laws and regulations, as well as of cGMP standards.
  • Some light lifting required, up to 25 pounds.
  • The position may also require occasional travel to other company locations and to external meetings. For immediate consideration please forward resumes to EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice

Keywords: Apex Systems, Milford , Regulatory Manager of North Americas, Executive , Milford, Connecticut