Regulatory Manager of North Americas
Company: Apex Systems
Posted on: February 21, 2021
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
- Prepare submissions and reports for government agencies as
required by product regulatory classification.
- Develop impact assessments and drive implementation of
- 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
- Build library and network of regional regulatory
- Maintain specialized product category knowledge. Required
Education, Skills and Experience
- B.A. / B.S. in regulatory affairs, chemistry, engineering, or
- 10+ years of related experience with a B.A. / B.S. degree,
within over-the-counter drugs, cosmetic and/or regulated consumer
- Knowledge and experience on FDA and Health Canada regulatory
and applicable laws and regulations, as well as of cGMP
- 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
Keywords: Apex Systems, Milford , Regulatory Manager of North Americas, Executive , Milford, Connecticut
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