Principle Regulatory Affairs Strategy Associate
Aequor JD ·www.aequor.com
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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
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
Frequently asked questions
Who is hiring for the Principle Regulatory Affairs Strategy Associate role?
Aequor JD is hiring for the Principle Regulatory Affairs Strategy Associate position, a Shazamme client. Apply directly on the employer's career site.
Where is the Principle Regulatory Affairs Strategy Associate job located?
The Principle Regulatory Affairs Strategy Associate role with Aequor JD is based in Lake Forest, CA, US.
Is the Principle Regulatory Affairs Strategy Associate role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Principle Regulatory Affairs Strategy Associate role?
The Principle Regulatory Affairs Strategy Associate position is aimed at junior-level candidates.
How do I apply for the Principle Regulatory Affairs Strategy Associate role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.