Senior Associate, Regulatory Affairs (Remote) Job at ICU Medical, Inc.
Job Title
Senior Associate, Regulatory Affairs
FLSA
Exempt
Remote Position
Position Summary
Provides regulatory support and expertise associated with drug product registrations for I.V. Solutions portfolio, including in-depth analysis of the requirements and tracking of deliverables. With some oversight, supports creation of regulatory strategies and assists in execution including creation and maintenance of registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management.
Essential Duties & Responsibilities
Essential Duties & Responsibilities
- Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations.
- Plans and organizes registration packages for drug products. Prepares registration packages in line with local regulatory requirements and guidelines.
- With oversight, serves as liaison with regulatory agencies pertaining to assigned products. Assists in the preparation of agency meeting packages and strategies for agency meetings.
- Evaluates CMC and labeling changes for regulatory impact with guidance. Accurately describes these changes for ease of regulatory agency review.
- Represents Global Regulatory Affairs at project team meetings and presents agreed upon regulatory positions. May serve as Global Regulatory Lead for an assigned product or project team.
- Support special projects and process improvement initiatives as assigned.
- Reviews and approves documents, seeking guidance when necessary. Reviews and provides input to technical reports for regulatory submission.
- Analyzes, interprets and summarizes scientific data as well as global regulations.
- Assesses scientific data provided for registration purposes to ensure it meets regulatory requirements.
- Identifies gaps in product submission and executes plans to mitigate the risk to approval, with management oversight.
- Responsible for tracking and completion of assigned registration activities and commitments. Accountable for accuracy of work and meeting deadlines.
- Provides regulatory support to project teams and for maintenance of commercial products with some oversight.
- Prepares and submits regulatory submissions.
- Successfully executes regulatory strategies.
- Makes independent judgments and decisions based on regulations and professional experience, with management oversight as appropriate.
Knowledge & Skills
- Emerging knowledge of applicable portions of agency regulations and guidance documents.
- Able to follow scientific arguments.
- Good oral and written communication skills.
- Good interpersonal skills.
- Developing negotiating skills and understanding of business needs
Minimum Qualifications, Education & Experience
- Bachelor’s degree from an accredited college or university is required, Masters preferred
- Seven or more years of pharmaceutical industry experience with a minimum of two years in Regulatory Affairs preferred.
- A degree in Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or a related field that will assist with providing guidance to technical teams, technical writing, and in problem solving technical issues as they relate to product development, manufacture and global registrations
- This is largely a sedentary role.
- Typically requires travel less than 5% of the time
This role is based remotely; the incumbent may be remote in any state other than Colorado; California; Connecticut; Montana, Maine or New York.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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