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Sr. Director, Regulatory Affairs

Company: LFB USA, Inc.
Location: Framingham
Posted on: September 12, 2020

Job Description:

Reporting to the Senior Vice President of Regulatory Affairs, the Sr. Director, Regulatory Affairs will work and mentor the Regulatory team in providing strategic leadership and direction in the implementation of strategies, policies, procedures and optimal infrastructure to ensure systems and processes are aligned with company submissions, LFB Corporate and applicable external regulatory authorities. This person/position will work closely with a number of LFB groups both in US and in France, and with external partners and/or 3 rd party clients, providing guidance and expertise. This person/position must be experienced and competent in both CMC and Clinical Regulatory deliverables and will participate in Agency interactions (correspondence, conference calls, in-person agency meetings, etc.).

Responsibilities Serve as a hands on member of the Regulatory team and provide leadership and review oversight to a team of strategic, compliance, operational, technical, professional and administrative staff that may or may not be direct reports. Provides guidance in interpreting government regulations and guidelines as they apply to products and practices.

Work with Quality to ensure Quality System procedures and practices meet regulatory standards.

Ensure products meet corporate and government standards and regulations.

Establishing and manage the compiling and reporting of department performance indicators. Make improvements and adjustments as required.

Assists in coordinating regulatory inspections and preparation.

Provide regulatory related input and review for internal programs across LFB Group as requested.

Interact directly with LFB Regulatory departments by both physical presence for such things as internal meetings, Mock Audits, input on submission development, submission reviews, and active participation in agency interactions and communications as appropriate.

Help anticipate, develop and manage departmental budget, monitoring project and program costs, actively participating in budget reviews.

Defines, develops and execute strategies to maximize regulatory success towards achievement of program objectives for complex and/or multiple projects.

Provides tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.

The Sr. Director will be responsible for overseeing an assigned portfolio of projects or highly complex projects. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the regulatory strategy is updated and executed, ensuring regulatory compliance and/or oversees direct reports or junior staff.

Ensures line management, project team colleagues and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.

Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Sr. Director will lead all submission types.

Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings. Oversees direct reports as needed.

Accountable for working with regulatory regional leads, other functions and vendors to ensure regulatory submissions are provided to LFB departments in compliance with local regulations and to maintain compliance for products.

Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.

Participates with influence in or leads departmental and cross-functional task-forces and initiatives.

Assists regulatory reviews of due diligence for licensing opportunities.

Partner with global market access colleagues to facilitate interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.

Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.

Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.

Travel up to 20% for business, both domestically and internationally.

Qualifications MS or advanced science degree (e.g. Ph.D, MD) and corresponding and commensurate industry experience (8+) with clear practical understanding of Regulatory Strategy, Regulatory Due Diligence, Clinical and CMC processes, Quality Assurance and GXPs as well as a strong Regulatory Affairs leadership background managing direct agency interactions and Agency response experience.

Experience with biologicals, CMC and clinical matters.

Knowledge of all business disciplines to ensure ability to ‘partner’ with all functional departments of the organization.

Demonstration of strategic planning, meeting objectives, technical and resource issue resolution.

Strong leadership capabilities with experience managing a team to high performance.

Computer proficiency and familiarity with MS software applications.

Excellent written and verbal communication skills, managing and adhering to timelines, negotiation skills, integrity and adaptability.

Ability to work and communicate with all levels within the organization.

Must practice constructive engagement and have the confidence to challenge and be challenged to get the best strategies and solutions.

Experience working for an International/Global Pharma company across differing countries (e.g. USA, EU, etc.) is of marked value .

Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

Preferred experience in authoring, reviewing, and preparing components of regulatory submissions.

Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, ROW and post-marketing a plus.

Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.

Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.

Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.

Ability and willingness to travel as some travel ( Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.

Keywords: LFB USA, Inc., Framingham , Sr. Director, Regulatory Affairs, Other , Framingham, Massachusetts

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