The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, lead and/or supervise IND/CTA and BLA submissions activities.
In this role, a typical day might include the following:
Provide interpretation of regulatory authorities' feedback, policies and guidelines.
Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation of major clinical submissions required for regulatory approval.
Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals.
Responsible for quality and timeliness of IND/CTA and BLA submissions. Interact with other functions and partners, in the preparation, review, and completion of documents for regulatory submissions.
Successfully plan, prioritize, supervise and/or conduct activities in close collaboration with leads from other areas. Assure compliance with regulations and with project team timelines.
Provide interpersonal support and lead personnel.
Excellent verbal and written communication skills
Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams
Ability to thrive in a fast-paced, entrepreneurial environment with successful colleagues
Ability to function at a high level in a team setting whether leading the group or acting individually
This role might be for you if:
If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals
You bring strong interpersonal skills both written and verbally
To be considered, you must possess excellent written and verbal communication skills along with a MD, Ph.D. or Pharm D. degree. We expect a minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.
This role requires you to work onsite 3 days per week in either Basking Ridge, NJ, Armonk, NY or Tarrytown, NY.