Regulatory Affairs Associate
- Employer
- Innovus Pharmaceuticals, Inc.
- Location
- San Diego, CA
- Salary
- 55,000-75,000 Depending on Experience plus performance bonus and benefits
- Start date
- Jul 13, 2021
View more
- Discipline
- Information Technology, Quality, Quality Assurance, Quality Control, Regulatory, Regulatory Affairs, General
- Required Education
- Bachelors Degree
- Position Type
- Full time
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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
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