178-1 Regulatory Affairs Manager

Job Description

Job Description

Onsite : San Rafael

Job Description :

• The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle.
• GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product.
• It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence.
• The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.
• The Regulatory Affairs Nonclinical / Clinical team plays a key role in defining the company’s regulatory strategy and pathway for a product by leading the development and execution of the nonclinical / clinical regulatory strategy and plan in alignment the overall clinical development plan.
• This team will take a lead role in planning and developing relevant sections of regulatory filings required for product approvals.
• In addition, this team will lead planning, coordinating and engaging directly with Health Authorities before, during and after regulatory approval milestones.

SUMMARY DESCRIPTION

KEY RESPONSIBILITIES :

Development Stage Product

Commercial Stage Product

General

EDUCATION AND EXPERIENCE

The hiring range for this position is $68 to $78 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.