B&H - Director, Regulatory Sciences
Company: VOISIN CONSULTING LIFE SCIENCES
Posted on: January 8, 2022
- 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
- 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
- Supervision of junior level team members, including performance
feedback, mentoring, training, and interviewing
- Direct strategic initiatives as a member of the Senior
- 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
- 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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