Position: Associate Director, Regulatory AffairsSummary: The Associate Director of Regulatory Affairs is responsible for contributing to and executing on global regulatory strategy and support as a member of multi-disciplinary teams. Support the process from development through to approval and ensure compliance with all US and international regulatory requirements.
Key Duties and Responsibilities:- Represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams as appropriate; leverage experience in regulatory affairs to provide guidance to colleagues for preparation of regulatory documents
- Serve as regulatory affairs contact for external parties (for example, CROs, advisors) involved in the conduct of Pulmovant's global clinical trials
- Contribute to the global regulatory strategy for submissions to support clinical trials and registration in accordance with applicable regulations/guidelines (for example, US FDA, EMA, PMDA, ICH, ISO)
- Plan, prepare, author, and/or review documentation and submissions (for example, IND, CTA, BLA, NDA, MAA) to health authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products
- Liaise with global health authorities as agreed with Director of RA and Head of RA
- Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
- Communicate project updates and risks to senior regulatory affairs management and stakeholders across the organization
- Track regulatory deliverables while coordinating with internal and external staff to ensure timely submissions
- Coordinate and prepare responses to requests for information from health authorities
- Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
- Contribute to the development of internal policy and procedures for regulatory affairs in alignment with GxPs, guidance documents, and corporate objectives
- Monitor, analyze, and disseminate intelligence on regulatory matters related to your assigned regulatory responsibilities
Education and Experience:- Education equivalent to a BS degree in a scientific field, plus 7 years of experience in regulatory affairs; or
- Education equivalent to a MS degree in a scientific field, plus 5 years of experience in regulatory affairs; or
- Education equivalent to a PhD/PharmD degree in a scientific field, plus 3 years of experience in regulatory affairs
- Experience working with the FDA is essential. Additional experience with EU, Japan and other global HAs is strongly preferred
- Experience with global clinical trials using a CRO
- Experience interacting with the FDA Division of Cardiology and Nephrology strongly preferred
- Experience with pulmonary hypertension and other pulmonary diseases a plus
- Experience in drug/device combination products a plus
- Regulatory Affairs Certification (RAC) in drugs and/or devices a plus
Essential Skills and Abilities:- Unquestionable integrity, being able to inspire trust, and exhibit the highest ethical standards
- Excellent communication, verbal and written, and interpersonal skills with a strong ability to interact with internal teams and partners across all levels of the organization
- Ability to effectively present information and respond to questions from all levels of the organization
- Sense of urgency, flawless execution with intense focus on accuracy and accountability
- Self-starter, highly motivated, assertive, driven, and hands-on leader
- Ability to multi-task in a fast-paced environment
- Operate collaboratively with colleagues across functional areas in a science-driven environment
- Ability to work well under pressure and meet time sensitive deadlines
- Ability to work across locations and time zones
- Highly proficient using Microsoft Word, Excel, PowerPoint, Adobe, and SharePoint; or similar applications and systems; experience with Veeva a plus
- Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget
- Travel up to 10% may be required to meet with vendors and regulators
We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!
