Manager, Regulatory Affairs

Otsuka ICU Medical•Austin, TX

1d•Remote

About The Position

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. Develop and execute global regulatory strategies to assure that new Otsuka ICU Medical drug products and changes to existing products are developed in line with regulatory requirements and guidelines. Develop high quality regulatory submissions for new products and maintain registrations of existing products in compliance with applicable regulations. Recommends and supports opportunities for process improvement.

Requirements

Advanced ability to critically assess scientific arguments and summarize complex technical data.
Advanced understanding of US and Health Canada drug regulations and available guidance documents / resources.
Strong project management skills and ability to manage multiple projects simultaneously
Collaborative leadership skills and able to lead and influence without authority
Follows scientific arguments, identifies regulatory scientific data needs and solves regulatory issues with supervision, where appropriate.
Excellent oral and written communication skills. Must be able to present scientific data effectively in a logical and persuasive manner.
Excellent interpersonal skills.
Well-developed negotiating skills. Strong understanding of business needs.
Bachelor’s degree from an accredited college or university is required; Advanced degree is preferred. A degree in Pharmacy, Biology, Chemistry, Pharmacology, or Engineering is preferred.
Seven to ten years of pharmaceutical industry experience with a minimum of five years in Regulatory Affairs with direct experience authoring original applications and supplements.
Experience successfully preparing original generic drug applications and supplements, and obtaining associated approvals
Experience successfully preparing and maintaining Type III Drug Master Files for container closure systems
Well-developed experience working directly with regulatory agencies. Sound knowledge of applicable portions of agency regulations and guidance documents.

Nice To Haves

Regulatory Affairs Certification preferred

Responsibilities

Develops regulatory strategies for development projects, CMC and labeling changes, advertisement and promotional materials, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by global regulatory authorities.
Acts as Global Regulatory Lead on cross functional teams, developing and executing regulatory strategies, communicating regulatory requirements and ensuring they are incorporated into program deliverables.
Manages the preparation of global registration packages and responses to requests for additional information. Negotiates submission data requirements and deliverable dates with internal technical teams.
Directs submission related activities by leading and motivating the team to successfully execute regulatory strategies.
Responsible for tracking and completion of assigned registration activities and commitments. Accountable for accuracy of work and meeting multiple, simultaneous deadlines
Acts as contact for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, and responses to agency letters pertaining to assigned projects.
Make independent judgments and decisions based on regulations and professional experience. Ensures alignment with Regulatory management as appropriate.
Evaluates changes for regulatory impact and ensures compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.
Reviews and approves critical documents, seeking guidance when necessary. Reviews technical reports and determines acceptability for regulatory submission.
Identifies gaps in product submission and executes plans to mitigate the risk to approval
Identifies opportunities for internal process improvements and offers solutions.