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Principle Regulatory Affairs Strategy Associate

Aequor Technologies LLC

Lake Forest, CA

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JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Business Development, Business Strategy, Communication Skills, Cross-Functional, Documentation, Due Diligence, English Language, GxP, International Law, Licensing, Maintain Compliance, Materials Tracking, Medical Equipment, Multitasking, Problem Solving Skills, Product Support, Product/Service Launch, Project Tracking, Project/Program Management, Quality Control, Regulations, Regulatory Compliance, Secondary School, Standard Operating Procedures (SOP), Time Management, Willing to Travel
LOCATION
Lake Forest, CA
POSTED
18 days ago
Description: Principle Regulatory Affairs Strategy Associate

The Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. You will plan and recommend regulatory strategies for pipeline products, actively participate in cross-functional teams, and influence business strategies to address regulatory needs.

Expectations / Responsibilities:

A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.

Oversee multiple projects within the Regulatory Affairs Strategy team, ensuring goals are met through self-directed work and effective supervision

Coordinate regulatory activities, including product submissions, renewals, and updates, by liaising with plants, agents, and governmental authorities to ensure timely submissions and approvals

Oversee promotional material approval for *** ME/KSA portfolio, ensuring ethical conduct and compliance with national and international laws, codes, and regulations

Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage

Support products in the medical device and/or pharmaceutical families, ensuring adherence to all relevant regulations

Make decisions impacting project performance and success, requiring project management, advanced problem-solving, effective communication, and industry-specific knowledge

Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training

Meet individual job requirements and contribute to the overall compliance of the organization



WHAT YOU LL BRING TO ***:

Bachelor s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)

The ability to fluently read, write, understand and communicate in English

7 Years of Relevant Experience

5 Years of Demonstrated Leadership

Location: Onsite, Lake Forest, CA

Travel Requirements: 0%

Custom Fields:
Name: System Access Required
Value: Yes

Name: Invoice Type
Value: USA-ARL-Staffing-USD

Name: Remote Worker
Value: No

Name: Badge ID Required
Value: Yes

Name: Worker Time Type
Value: Full Time

Name: Supervisory Org
Value: Surgical - Instrumentation(Khalid Mansoor)-60004887

Name: Work Desk Phone Number Required
Value: No

Name: Workspace
Value: None

About the Company

A

Aequor Technologies LLC

COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies

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