Manager, Regulatory Operations

Employer
Retrophin
Location
San Diego, California
Posted
Aug 27, 2020
Ref
R-100054
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
At Retrophin, our mission is to identify, develop and deliver life-changing therapies to people living with rare disease. Giving patients a chance, providing hope, is what drives us.

Retrophin recognizes that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of patients. Our work is rewarding, professionally and personally because we are making a difference and we are passionate about what we do.

We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast paced environment and share in our mission to help others. We are headquartered in San Diego, CA with additional offices in Dublin, Ireland.

Position Summary:

This position reports to the Associate Director, Regulatory Operations and is responsible for operational aspects of global regulatory submissions, ensuring that submissions are high quality and submitted on-time. This role is also responsible for archiving and tracking regulatory submissions and health authority correspondence. This position will collaborate productively with all functional areas providing submission relevant documentation for regulatory dossiers, and ensure documents and submissions comply with regulatory and company guidances/specifications. This position is in Retrophin's corporate headquarters in San Diego, CA.

Essential Functions:
  • Prepare global regulatory electronic submissions, ensuring submission timelines and submission quality standards are met.
  • Ensure quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
  • Provide guidance on good documentation and submission practices.
  • Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures in accordance with all applicable Regulatory regulations, guidances, and specifications.
  • Interact with internal departments, consultants, and vendors to implement and maintain processes and quality control checks, ensuring all information provided in the context of electronic submissions is accurate, complete and meets regulatory specifications.
  • Maintain effective interactions with contributors and Regulatory leadership, to ensure timely delivery of regulatory submissions.
  • Provide document authoring template training.
  • Provide Document Management System (DMS) training.
  • Identify regulatory system improvement needs or technical issues and work closely with systems and technical support staff to identify, develop, and implement solutions.
  • Identify potential risks to submission plans and propose risk mitigation strategies.
  • Maintain current knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, etc.).


Qualifications:
  • Bachelor's Degree in Life Science or other related discipline. An equivalent combination of education and applicable job experience can be considered.
  • Minimum of 6 years of Regulatory Operations experience in biotech/pharmaceutical industry.
  • Experience working in a Document Management System (DMS) required.
  • Working knowledge of Veeva Vault software, across multiple vaults including RIM suite, Platform, eTMF, Quality Docs, and QMS preferred
  • Working knowledge of the eCTD structure and publishing software, and global electronic submission requirements are required.
  • Advanced proficiency using Microsoft Word and Adobe Acrobat Professional is required.
  • Advanced proficiency administering and maintaining document authoring templates.
  • Team player capable of managing multiple projects and complex timelines in a team environment.
  • Ability to problem solve and troubleshoot under pressure to ensure timely and compliant submissions to global health agencies.
  • Strong attention to detail and the ability to multi-task in fast paced environment.
  • Positive attitude, energetic and proactive.
  • Strong interpersonal, verbal/written communication, analytical and organizational skills.
  • Excellent team player skills, ability to lead, train and mentor team members in multiple disciplines.
  • Works independently under general supervision. Exercises judgment within generally defined practices and policies.
  • Ability to travel 5% domestic and internationally.


Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer

Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer