Senior Manager, Regulatory Lead

About the role

Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. As Manager Regulatory Lead you will be accountable for recommending and implementing regulatory strategy and coordinating life cycle activities across the portfolio of PDT products.

• Serves as the regulatory lead for one or more projects and coordinates the Global Regulatory Team (GRT) meetings composed of core regulatory support functions.
• Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of plasma derived therapies, while ensuring compliance with applicable regulatory requirements.
• Liaises with the US FDA on submissions within their responsibilities.
• Serves as the lead interface between PDT global regulatory affairs, global subject matter experts, international LOCs, EU & Canada strategy, Japan and China, to facilitate the collection of regulatory documentation for new registrations and license maintenance.
• Assists in the creation and execution of global regulatory strategies for assigned programs and ensures the global regulatory strategies for assigned programs are up-to-date.
• Collaborates with EU & Canada, Japan, China and/or other regional counterparts in compiling global regulatory strategies and works cross-functionally with RA and R&D program team members to ensure critical deliverables to countries/regions outside the US are achieved and timely execution of the strategy is met.
• Supports global regulatory subteam (GRT) and cross-functional subteams and working group to execute regulatory submissions. Assists in the creation and submission of high quality, compliant regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) for assigned programs within defined timelines as per R&D and business objectives.
• Responsible for regulatory submissions for assigned programs. Works cross-functionally with RA and R&D program team members to ensure critical deliverables to countries/regions outside the US are achieved and timely execution of the strategy is met.
• Assists with FDA health authority interactions/meetings related to assigned programs and supports regional and local regulatory affairs teams with health authority interactions.
• Identifies and notifies management of any resource gaps for project responsibility. Demonstrates ability to anticipate risks and is responsible for developing solutions to identified risks and discussing with the assigned team and management; understands probabilities of technical success for the solutions.
• Ensures accurate, up-to-date reporting of program status and milestones globally through the InterACT system and regulatory dashboard and leverages the Dragonfly visualization tool to highlight any major discrepancies for assigned programs.
• Collaborates with LOCs to identify the documents required for submissions, identifies responsible PDT subject matter experts and facilities alignment on deliverables and timelines.

• BSc degree preferred and advanced degree a plus. BA accepted.
• Minimum of 4 years of pharmaceutical industry experience, with a minimum of 2 years within a regulatory strategy role.
• Plasma or biologics experience preferred.
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
• Knowledge of global regulatory requirements and prior FDA interactions/submissions experience.
• Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Demonstrates skills and ability to work well in a matrixed environment to deliver on tactics.

Boston, MA

U.S. Base Salary Range: $ - $

Employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision, 401(k) plan with company match,…