Director, Regulatory Sciences

Position:          Associate Director/Director, Regulatory Sciences

Responsibilities include:

  • 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
    • 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.
    • Prior experience with eDRLS submissions.
    • Knowledge and experience with eCTD.
    • 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. RAC and/or MS/Ph.D. are 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.

Additional Information

  • Equal Opportunity Employer
  • All resumes are held in confidence
  • Must be eligible to work in the US