Regulatory Affairs Associate

Location
San Diego, California
Salary
45,000-65,000 Depending on Experience
Posted
Mar 20, 2018
Required Education
Bachelors Degree
Position Type
Full time

REGULATORY AFFAIRS ASSOCIATE 

The Regulatory Affairs Associate will prepare regulatory submissions for our OTC drugs, devices, supplements and consumer care products,  and interact with regulatory agencies/health authorities to obtain and maintain product approvals. Participate in international and local regulatory intelligence groups and represent Regulatory Affairs on the product life-cycle management teams as needed. Prepare SOPs for supply chain and perform other duties as needed

Essential Responsibilities

Responsibilities:

  • Generate regulatory reports to communicate worldwide registration activities
  • Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives
  • Interact with global regulatory leaders and peers to expedite approval of pending registrations         
  • Interact with departments to generate protocols and reports that require in-country testing data for registration purposes
  • Maintain a "focused urgency" as required by specific events  
  • Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors  
  • Assess potential impact and/or applicability to other related areas   
  • Assess corrective action to assure it prevents recurrence   
  • Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions  
  • Provide regulatory training to cross-functional groups 
  • Prepare SOPs for different departments  

 

Qualifications

Required Knowledge Skills and Abilities

  • Bachelor’s degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level
  • A minimum of 3-5 years of direct related experience in regulatory within OTC, supplements, consumer care products and medical devices
  • Sound basis of Regulatory and /or Scientific knowledge
  • Strong PowerPoint, Excel and Word knowledge
  • Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
  • Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations
  • Able to confidently deal with ambiguous issues and provide input towards suitable actions
  • Strong oral and written communication and presentation skills
  • Effective communicator of technical & non-technical information
  • Ability to work in a self-directed manner to see issues through to completion
  • IVD product experience is highly preferred
  • International submissions experience is preferred

 

Required Knowledge Skills and Abilities

  • Bachelor’s degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level
  • A minimum of 3-5 years of direct related experience in regulatory within an IVD or medical device manufacturing site
  • Sound basis of Regulatory and /or Scientific knowledge Strong PowerPoint, Excel and Word knowledge Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
  • Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations
  • Able to confidently deal with ambiguous issues and provide input towards suitable actions
  • Strong oral and written communication and presentation skills
  • Effective communicator of technical & non-technical information
  • Ability to work in a self-directed manner to see issues through to completion
  • OTC and supplements product experience is highly preferred
  • International submissions experience is preferred