International Regulatory Manager in Milford, CT US at Apex Systems

Company: Apex Systems Inc.
Location: Milford
Posted on: February 25, 2021

Job Description:

International Regulatory Manager in Milford, CT US at Apex Systems With emphasis on cosmetic and personal hygiene products--for the regions of Asia-Pacific, Europe and Latin America, this role provides regulatory guidance and advises on regulatory requirements. This position will develop strategies for governmental approval to introduce new products to market and manages submissions for pre-market approval. The Manager will assist with the training of regulatory affairs personnel and provides direction on specific projects in addition to having supervisory responsibility for one or more colleagues. Hands-on responsibilities for the support of product registrations and company licensing needs will be a part of this role. Responsibilities

• Manage and implement Regulatory Affairs strategies, policies, and objectives in accordance with Company strategic plans.
• Ensure all governmental reporting systems and documentation comply with applicable regulatory standards and requirements for OTC drug, cosmetic, consumer and other products.
• Monitor and interpret changes in laws, standards, and regulations and determine impact to business.
• Provide regulatory guidance, risk assessment, and management throughout the product lifecycle for both New Product Development and Commercial projects.
• 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.--
• Manage the pre-market registration or notification process to enable product sale.
• Maintains up to date product registration/license portfolio for applicable countries/regions.
• 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. Requirements:
  • B.A. / B.S. in regulatory affairs, chemistry, engineering, or life sciences OR 3 years of direct, related experience
  • 10+ years of related experience within over-the-counter drugs, cosmetic and/or regulated consumer products OR 13+ years of related experience within over-the-counter drugs, cosmetic and/or regulated consumer products in lieu of bachelor's degree
  • Strong knowledge and experience on Asia-Pacific, Europe and Latin American regulatory frameworks and applicable laws and regulations for Cosmetics and Personal Care/Hygiene products.
  • Some light lifting required, up to 25 pounds. For immediate consideration please forward resumes to mmoncrieffe@apexsystems.com EEO Employer Apex 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 employeeservices@apexsystemsinc.com or 844-463-6178. Apex 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 employeeservices@apexsystems.com (Do not submit resumes or solicit consultants to this email address) or 844-463-6178. Join our Talent Network!

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