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Principle Regulatory Affairs Strategy Associate

Sunrise Systems Inc

Lake Forest, CA

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JOB DETAILS
SALARY
$79.71–$83.33 Per Hour
SKILLS
Biotech and Pharmaceutical, Business Development, Business Strategy, Communication Skills, Cross-Functional, Documentation, Due Diligence, English Language, GxP, International Law, Leadership, Licensing, Maintain Compliance, 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
19 days ago
Job Title: Principle Regulatory Affairs Strategy Associate
Location: Lake Forest, CA - ONSITE
Duration: 6-8 months on W2 contract with potential to extend

Job 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 approvalsOversee promotional material approval for Alcon 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 CLIENT:
  • 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%

Compensation: 
 
The hourly rate for this position is between $79.71-$83.33 per hour.  
 
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate]. 

Contact:
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com

About the Company

S

Sunrise Systems Inc

Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.

We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.

Our collective business experience spans over two and a half decades and ranges from:

  • Business, management, and technical fields
  • Information technology consulting and software solutions.
  • Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
  • Motivating technology staff and establishing partnerships with Fortune 500 companies

Sunrise Systems has a vast range of competence in:

  • Design, development, and support of cloud-based solutions from simple to highly complexed
  • Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
  • Data processing and data migration
  • Application re-engineering and platform migration
  • Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1990
WEBSITE
http://www.sunrisesys.com/

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