Title:  Senior Specialist Regulatory Affairs

About the Job

Serves as the Subject Matter Expert (SME) for publishing and some regulatory activities for R&D. This includes, but is not limited to the publishing, compilation, review, and submission of pre-approval (R&D) submissions, such as original applications, amendments, deficiency responses, and general correspondence for all regulatory submissions with a focus on Chemistry, Manufacturing and Controls (CMC).  Required to mentor and provide regulatory support as the SME to other associates in the group, in applicable project team meetings, as well as within the organization as it applies to regulatory interpretation, application and strategy. Expected to meet all submission timelines to ensure timely and quality submissions to support the business. Requires minimal supervision.

Key Responsibilities

• Regular and predictable attendance and punctuality.

• Publishing documents for submission of ANDAs, NDAs, INDs, amendments, and supplements in compliance with current FDA requirements with minimal oversight.  Coordinating with project team members to ensure timely and accurate submissions.  Providing troubleshooting support of technical issues. Providing assistance as needed with document formatting and compliance with required FDA specifications.

• Reviewing compiled submissions prior to being sent to regulatory agencies for technical compliance to current regulations.

• Directly interfacing with project teams to manage the preparation of their documents; providing expert publishing assistance for all documents critical to regulatory submissions.  Ensuring documents are compliant with Corporate policies and Guidelines, as well as Regulatory Guidance documents.  Critically reviewing submission documentation and providing input to respective departments for necessary revisions.

• Staying current with industry expectations and standards.  Evaluating processes and working towards applicable improvements to gain efficiency and Right First-Time objectives. Providing mentoring and being an eCTD technical resource for Regulatory, Labelling and R&D personnel with respect to publishing activities in order to help drive the business and increase functional exposure.

• Compiling, reviewing and submitting R&D (Pre-approval) changes for the US market. Regulatory submissions such as annual reports and supplements (Post-approval) for ANDAs and NDAs will be submitted to FDA as per the business needs and in compliance with all FDA requirements.

• Reviewing change controls for regulatory impact and documentation to be included in regulatory submissions.

• Working closely with cross-functional departments to provide the appropriate regulatory requirements/guidance, as applicable.

• Assisting in the development and/or improvement of regulatory best practices, processes, and procedures.

• Other duties as assigned.

What We Expect

• Bachelor’s Degree in a scientific or technical field

• 2 - 5 years of pharmaceutical experience specifically in publishing, formulation, analytical lab or QC lab, or Quality Assurance documentation.

• Direct regulatory affairs experience is preferred.

• Interact with all levels of the organization and facilitate meetings and drive agreement with partners across the business.

• Make daily decisions that directly impact the quality of submissions and the overall business.

• Decipher between requiring higher level input and input at the analyst level.

• Manage multiple projects and timelines with minimal supervision.

• Excellent verbal and written communication skills.

• Thorough understanding and working knowledge of regulatory requirements for both pre-approval and post-approval submissions for the US Market.

• Attention to detail.

• Critical thinker.

• Ability to work independently.

• Demonstrates the ability to ensure high quality submissions to US FDA.

• Thorough understanding of regulations and requirements for US market through expert knowledge, FDA guidance documents and MAPPs, ICH Guidelines, CFR as they pertain to generic drug products. 

What We Offer

• A dynamic work environment

• Opportunities to interact with colleagues at all levels, as well as clients and customers

• 30 vacation days per year

• Annual health check-up

• Monthly food and travel allowances