Director, Regulatory Sciences
Position: Associate Director/Director, Regulatory Sciences
- 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.
- 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:
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.
- Equal Opportunity Employer
- All resumes are held in confidence
- Must be eligible to work in the US