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Director, Regulatory Affairs

Company: Amazon Workforce Staffing
Location: Framingham
Posted on: September 17, 2020

Job Description:

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 theRegulatory team in providing strategic leadership and direction inthe implementation of strategies, policies, procedures and optimalinfrastructure to ensure systems and processes are aligned withcompany submissions, LFB Corporate and applicable externalregulatory authorities. This person/position will work closely witha number of LFB groups both in US and in France, and with externalpartners and/or 3 rd party clients, providing guidance andexpertise. This person/position must be experienced and competentin both CMC and Clinical Regulatory deliverables and willparticipate in Agency interactions (correspondence, conferencecalls, in-person agency meetings, etc.).

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

Work with Quality to ensure Quality System procedures andpractices meet regulatory standards.

Ensure products meet corporate and government standards andregulations.

Establishing and manage the compiling and reporting ofdepartment performance indicators. Make improvements andadjustments as required.

Assists in coordinating regulatory inspections andpreparation.

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

Interact directly with LFB Regulatory departments by bothphysical presence for such things as internal meetings, MockAudits, input on submission development, submission reviews, andactive participation in agency interactions and communications asappropriate.

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

Defines, develops and execute strategies to maximize regulatorysuccess towards achievement of program objectives for complexand/or multiple projects.

Provides tactical advice to teams to achieve timely andefficient development and maintenance of programs, while ensuringcompliance with applicable regulatory requirements.

The Sr. Director will be responsible for overseeing an assignedportfolio of projects or highly complex projects. Definesstrategies and provides tactical guidance to teams and collaboratescross-functionally to ensure the regulatory strategy is updated andexecuted, ensuring regulatory compliance and/or oversees directreports or junior staff.

Ensures line management, project team colleagues and keystakeholders are apprised of developments that may impactregulatory success, exercising sound judgement and communicating ina professional and timely manner. Demonstrates ability toanticipate risks and responsible for developing solutions toidentified risks and discussing with team and management;understands probabilities of technical success for thesolutions.

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

Direct point of contact with health authorities, leads andmanages FDA/health authority interactions/meetings. Oversees directreports as needed.

Accountable for working with regulatory regional leads, otherfunctions and vendors to ensure regulatory submissions are providedto LFB departments in compliance with local regulations and tomaintain compliance for products.

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

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

Assists regulatory reviews of due diligence for licensingopportunities.

Partner with global market access colleagues to facilitateinteractions with joint regulatory/health agency/HTA bodies onproduct specific value evidence topics, as applicable.

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

Understand and interpret complex scientific issues acrossmultiple projects as it related to regulatory requirements andstrategy.

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

Travel up to 20% for business, both domestically andinternationally.

Qualifications MS or advanced science degree (e.g. Ph.D, MD) andcorresponding and commensurate industry experience (8+) with clearpractical understanding of Regulatory Strategy, Regulatory DueDiligence, Clinical and CMC processes, Quality Assurance and GXPsas well as a strong Regulatory Affairs leadership backgroundmanaging direct agency interactions and Agency responseexperience.

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 teamto high performance.

Computer proficiency and familiarity with MS softwareapplications.

Excellent written and verbal communication skills, managing andadhering to timelines, negotiation skills, integrity andadaptability.

Ability to work and communicate with all levels within theorganization.

Must practice constructive engagement and have the confidence tochallenge and be challenged to get the best strategies andsolutions.

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

Demonstrates acceptable skills with increasing independence inthe area of regulatory strategy such as understanding broadconcepts within regulatory affairs and implications across theorganization and globally; proactively identifies regulatoryissues; offers creative solutions and strategies, including riskmitigation strategies.

Preferred experience in authoring, reviewing, and preparingcomponents of regulatory submissions.

Solid working knowledge of drug development process andregulatory requirements. Knowledge of FDA, EU, ROW andpost-marketing a plus.

Understand and interpret complex scientific issues acrossmultiple projects as it related to regulatory requirements andstrategy.

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

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

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

Keywords: LFB USA, Inc., Woonsocket , Sr. Director, Regulatory Affairs, Other , Framingham, Rhode Island

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Keywords: Amazon Workforce Staffing, Framingham , Director, Regulatory Affairs, Other , Framingham, Massachusetts

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