Senior Manager, Regulatory Operations

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 Senior Director, Regulatory Operations and is responsible for operational aspects of global regulatory submissions, ensuring that submissions are high quality and submitted on a timely basis This role is also responsible for archiving and tracking regulatory submissions and health authority correspondence. Additional key accountabilities include working with Regulatory Affairs, Medical Writing, Biometrics, Clinical, Medical, and Technical Operations subject matter experts and authors and Regulatory Agencies, to ensure documents and submissions comply with regulatory and company guidance /specifications.

Qualifications:

• Manages the development of compliant GXP electronic systems; plans, prepares, and tracks regulatory electronic documents and submissions ensuring conformance with regulatory requirements, guidelines, internal standards and timelines.
• Manages global regulatory electronic submissions, ensuring submission timelines and submission quality standards are met.
• Develops departmental procedures outlining the generation of electronic submission-ready documents.
• Interacts and partners 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.
• Serves as subject matter expert in dossier types and/or processes with responsibility for training and mentoring regulatory operations staff and representatives from cross-functional teams.
• Identifies potential risks to submission plans and proposes risk mitigation strategies.
• Provides recommendations on resource needs for regulatory operations activities including the need for outsourcing (e.g., eCTD vendor, SPL vendor).
• Maintains current knowledge of FDA, Health Canada, EMA, and ICH requirements for regulatory submissions and ensures that all regulatory submissions comply with those requirements.

Position Requirements:

• Bachelor's Degree in Life Science or other related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered.
• Minimum of 6 years' regulatory experience in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 5 years' experience in a regulatory operations role.
• Strong professional experience in a similar role within the pharmaceutical industry, preferably small molecule pharmaceuticals.
• Demonstrated track record of successful approvals from a major regulatory agency is required.
• Functional knowledge of Veeva Vault software, across multiple vaults including RIM suite, Platform, eTMF, Quality Docs, and QMS preferred
• Strong expertise and knowledge of the eCTD structure and publishing software, and global requirements is required.
• Strong knowledge of submission data standards (CDISC) is required.
• Advanced proficiency using Microsoft Office Suite and Adobe Acrobat Professional is required.
• Advanced proficiency administering and maintaining document authoring templates.
• Ability to problem solve and troubleshoot under pressure to ensure timely and compliant submissions to global health agencies
• Continued assessment of revisions to requirements for electronic submissions, both pre- and post -approval.
• Team player capable of managing multiple projects and complex timelines in a team environment.
• Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Successful record of creating and managing complex project plans, timelines, budgets and critical paths.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Demonstrated capacity to work in a highly matrixed working environment by interacting effectively with internal departments and external organizations.
• Ability to lead, train and mentor team members in multiple disciplines, as needed
• Works independently under general supervision and exercises judgment within generally defined practices and policies.
• Ability to travel 5% domestic and internationally.

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