MilfordRecruiter Since 2001
the smart solution for Milford jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Manager In Training
Description: At Nouria our business is about our people and we want you to achieve your goals in your career path. Whether you're looking for a part time position, store management or a corporate role, Nouria is the (more...)
Company: Nouria Energy
Location: East Providence
Posted on: 03/4/2021

SAP QM (Quality Management) consultant
Description: ACS Solutions has an immediate need for a SAP QM Consultant with experience in the Pharmaceuticals Industry. This is a 6 months contract opportunity and is located in New Brunswick, NJ. Our client
Company: Analysts
Location: New Brunswick
Posted on: 03/4/2021

Director - Projects
Description: Sorry--- The job you are trying to applied for has been filled Maybe you would like to consider the Categories below : Equal Employment Affirmative Action Policy: Cognizant is an equal opportunity employer. (more...)
Company: Cognizant
Location: Hoboken
Posted on: 03/4/2021

Accelerated Retail Store Management Program - Wayne, NJ
Description: Accelerated Retail Store Management ProgramApply today to learn more about why Bridgestone Retail Operations Is the right place to build your career https://www.bebridgestone.comJob Summary:An accelerated (more...)
Company: Bridgestone Retail Operations, LLC
Location: Wayne
Posted on: 03/4/2021

Santander Holdings USA Inc: Vp, Capital Markets Production Support
Description: VP, Capital
Company: Santander Holdings USA Inc
Location: Holtsville
Posted on: 03/4/2021

Vendor Management Specialist
Description: The Vendor Management Specialist is responsible for coordinating vendor relationships and Third-Party oversight through the on-boarding/off-boarding process.Responsibilities
Company: Valley Bank
Location: Wayne
Posted on: 03/4/2021

Nurse Manager - Days Full-Time
Description: Hawthorne House provides exceptional care to the Freeport, Mid-Coast, and surrounding communities offering long-term, rehabilitation, mental health, and memory care to a wonderful group of Residents. (more...)
Company: First Atlantic Health Care
Location: Freeport
Posted on: 03/4/2021

Sr. Product Manager - Ad Platform Commercialization
Description: Job Summary:DMED Ad Platforms is responsible for delivering global adverting technology solutions for Disney's Linear and Addressable channels, brands and streaming services. With unmatched scale, premium (more...)
Company: Disney Media & Entertainment Distribution
Location: Hempstead
Posted on: 03/4/2021

Project Manager - Cell Therapies
Description: Advanced Therapy AT is newly created cross divisional Business Unit within Sartorius, with the aim to increase market share of the complete Sartorius portfolio for Cell Therapy market. The Advanced (more...)
Company: Sartorius AG
Location: Bohemia
Posted on: 03/4/2021

Sr. Manager, Performance Marketing
Description: Privilege Underwriters, Inc. is the insurance holding company dedicated to creating an exceptional experience for responsible high net worth individuals and families that are members of Privilege Underwriters (more...)
Company: PURE Insurance
Location: White Plains
Posted on: 03/4/2021

Log In or Create An Account

Get the latest Connecticut jobs by following @recnetCT on Twitter!

Milford RSS job feeds