Sr. Regulatory Specialist

Job Description

Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.

Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies.

Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.

Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk.

Reviews product labeling and marketing materials for accuracy and compliance with regulations.

Responds to customers’ and/or authorities’ requests/inquiries dealing with regulations and product compliance.

Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level.

May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.

Qualifications

Bachelor's or Master's Degree or equivalent.

Post-graduate, certification, and/or license may be required.

Typically, at least 3+ years relevant experience.

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Option to Work Remote

Yes

Travel Required

No

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

Administration