Regulatory Product Manager Jobs

Special Knowledge, Skills and Abilities:

Strong analytical skills and demonstrated problem-solving abilities

Good working knowledge of Company operations, processes, products and services Solid PC Skills, including Excel, Word, PowerPoint

Develops and implements regulatory guidance strategies for new and existing product and service offerings to meet business objective. (20%)

Strong interpersonal skills in order to interact professionally with Commission Staff, Industry Associations/Coalitions, internal departments and other external stakeholders as required.

Knowledge of current regulatory issues, rules and environment (Federal and State)

Crisis Management: Assist in handling product-related crises or recalls, coordinating efforts to address safety concerns and regulatory issues promptly.

Bachelor's degree in a relevant field, such as Regulatory Affairs, Product Management, or a related discipline.

Product Documentation: Manage and organize product documentation, including specifications, testing reports, and certificates, to support compliance efforts.

Labeling and Packaging: Review and approve product labeling, packaging materials, and marketing materials to ensure they adhere to regulatory requirements.

Knowledge of relevant regulations and standards in the industry, with a strong focus on product safety and compliance.

Strong attention to detail and organizational skills.

Establish system and procedures for product specification collection and management.

Bachelor’s Degree in Arts/Sciences (BA/BS) Chemistry, Chemical Engineering, Biochemistry, Biology or related science disciplines of quality assurance management. required.

Factory auditing (cGMP, supplier qualification, CTPAT and Social Compliance)

7 years of experience in Roles of increasing complexity in Compliance and/or Quality Assurance function in a Retail company required.

5 years of experience in Experience in developing quality assurance programs supported by a record of implementing continuous improvement programs required.

Oversee team that identifies, interprets, develops and implements product-based quality and regulatory compliance strategies.

Promoting cross-training, knowledge management, and problem-solving across the organization.

5+ years of experience in program management, design, implementation or ongoing operations management

Experience in a client facing/vendor management role

Assist the Sr. Manager with project management for cross-functional initiatives.

(A bachelor's degree or commensurate 4 years of experience

5+ years of work experience in health insurance, consulting, healthcare, and operations

EDUCATION, TRAINING AND EXPERIENCE REQUIREMENTS

• Provide research, interpretation, and summary of regulatory requirements relevant to regulated substances.

• Provide education and training on product compliance with regulations for sales, Client Development, and Business Development.

• Author CHT USA Safety Data Sheets to ensure full compliance with US and other country requirements.

o 5-7 years of industrial chemistry experience

o 2-3 years of regulatory experience preferred

Manage all the databases, as per local regulation (e.g. EudraCT European database and EudraCT number request, ClinicalTrials.gov)

If necessary, directly manage ethical/administrative submissions

Conduct with his/her direct Manager annual performance review for his/her staff and provide career development opportunities

Degree level education is a plus preferably in pharmacy, medicine, or biological sciences

Minimum of 3 years professional experience, including previous experience in Regulatory or Start-up functions at a local/country level

At least 1 years of hands-on experience in the submission of clinical trial applications

• Perform other related duties as requested.

• Provide support for requests for regulatory-related documentation and aid in resolution of issues requiring regulatory review/oversight.

• Aid in review of engineering requested product changes (ECR) for regulatory impact. Authorized to approve changes.

• Review product labeling to ensure compliance with registrations.

• Support external regulator or customer audits.