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B&H - Director, Regulatory Sciences

Location: Somerville
Posted on: January 8, 2022

Job Description:

  • B&H - Director, Regulatory Sciences - USA Job B&H - Director, Regulatory Sciences - USA Regulatory Strategy, Agency Interaction and Submission Support
    • Provide regulatory expertise related to the design and implementation of strategies for the development of new drugs, biologics, medical devices and/or combination products (drug/drug or drug/device).
    • Provide regulatory guidance and submission strategy to clients based on FDA, EU, and ICH guidelines.
    • Direct interactions with FDA as US agent/regulatory agent for designated ex-US and US clients, respectively, serving as the primary FDA contact.
    • Develop and submit Sponsor Meeting Requests and Briefing Packages; facilitate meeting rehearsals and participate in meetings with FDA. As necessary, lead such FDA meetings.
    • Write or review documents, as applicable, and compile regulatory dossiers for submission to FDA and/or global health authorities, including but not limited to: IND, NDA, BLA, amendment, supplement, IMPD, DMF, etc.
    • Prepare and/or review and coordinate life cycle management submissions for all types of regulatory filings. Project Management
      • Manage multiple projects - coordinate/discuss project specifics with clients; establish timelines for submissions; manage submission content plans; prepare or review documents for submission to regulatory agencies, as applicable.
      • Work with the B&H team to ensure efficiency in submission process. Leadership
        • Supervision of junior level team members, including performance feedback, mentoring, training, and interviewing
        • Direct strategic initiatives as a member of the Senior Leadership Team
        • Help maintain B&H's workplace culture that emphasizes the strengths and values of the B&H processes and the integrity of submissions. Business Development
          • Support business development activities and represent B&H to potential/new clients.
          • Prepare Statements of Work (SOWs). The ideal candidate will possess the following qualifications: Experience: Knowledge of regulatory sciences as demonstrated through a combination of work experience and academic background:
            • Prior professional experience in pharma, bio tech, or medical devices companies.
            • Prior experience with regulatory submissions and interactions with the FDA or other Health Authorities.
            • Knowledge and -experience with eCTD.
            • Ability to interpret and apply regulations as they apply to specific project issues: 21 CFR, FDA, ICH, or other regulatory agency guidance requirements.
            • Experience in a consulting environment is a plus.
            • BS/BA in Regulatory Sciences or Life Sciences with a balance of work experience. RAC and/or MS preferred. Ph.D. a plus. You may be at a career crossroad where continuing to learn and being challenged coupled with work flexibility in an apolitical corporate environment is appealing. Personal attributes and skills
              • Project management skills: research, planning, scheduling, documentation, and project control.
              • Strong attention-to-detail, organization/multitasking, teamwork, and communication (verbal/written) skills.
              • Consulting skills: influencing, advising, facilitating, diplomacy, critical thinking, adaptable, and presenting.
              • Problem-solving abilities and a self-starter.
              • Leadership and supervisory skills.
              • Professional and courteous work demeanor in interactions with colleagues, clients, and regulatory authorities.
              • Business Development skills to identify clients/project opportunities and prepare SOW's.
              • Ability to work under deadlines to meet project timelines, including the ability to modify work schedule when needed.
              • Computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) and Adobe Acrobat.
              • Maintain company values and demands the highest standards of conduct from self and others. Yes, I would like to receive communications regarding VCLS services and events

Keywords: VOISIN CONSULTING LIFE SCIENCES, Somerville , B&H - Director, Regulatory Sciences, Executive , Somerville, Massachusetts

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