Roivant Sciences

Senior Director, Regulatory Affairs, Pulmovant

Roivant Sciences • $160K — $200K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BS in scientific field with 15+ years in regulatory affairs; or MS with 12-15 years; or PhD/PharmD with 8 years of experience.
  • Proven experience in leading NDA preparation and submission processes.
  • Essential experience with FDA; additional experience in EU, Japan, and other global health authorities preferred.
  • Preferred experience interacting with FDA Division of Cardiology and Nephrology.
  • Desirable knowledge in pulmonary hypertension and drug/device combination products.
  • Regulatory Affairs Certification (RAC) is a plus.

Responsibilities

  • Represent Regulatory Affairs in project meetings, providing regulatory guidance to multi-disciplinary teams.
  • Serve as the regulatory contact for external parties in global clinical trials.
  • Develop and implement regulatory strategies for clinical trial submissions.
  • Prepare and review documentation for submissions to health authorities.
  • Liaise with global health authorities as needed for project support.
  • Track regulatory commitments and submissions while coordinating internally and externally.
  • Contribute to competitive regulatory strategies to mitigate risks and maximize success.

Benefits

  • Comprehensive health and wellness programs.
  • 401(k) retirement savings plan with company matching.
  • Flexible work arrangements to support work-life balance.
  • Professional development opportunities and training.
  • Supportive and collaborative team culture.
Full Job Description
Position: Senior Director, Regulatory Affairs

Summary

The Senior Director of Regulatory Affairs is responsible for providing global regulatory strategy and support as a member of multi-disciplinary teams. Manage 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
  • Develop and implement a 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 needed
  • 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
  • Tracking regulatory commitments and 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
  • Provide input into 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 that may affect ongoing development programs
  • Participate in due diligence evaluations of potential in-license/partnering opportunities


Education and Experience
  • Education equivalent to a BS degree in a scientific field, plus 15+ years of experience in regulatory affairs; or
  • Education equivalent to a MS degree in a scientific field, plus 12-15 years of experience in regulatory affairs; or
  • Education equivalent to a PhD/PharmD degree in a scientific field, plus 8 years of experience in regulatory affairs
  • Recent experience leading the preparation, submission and approval process for an NDA
  • Experience working with the FDA is essential. Additional experience with EU, Japan and other global HAs is strongly preferred.
  • 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

About Roivant Sciences

Roivant Sciences is a biopharmaceutical company that focuses on developing and commercializing innovative therapies. The company was founded in 2014 by Vivek Ramaswamy and is headquartered in New York City. Roivant Sciences is a unique company that operates as a family of independent biopharmaceutical companies, each focused on a specific therapeutic area. The company's mission is to reduce the time and cost of developing new drugs and to bring them to market faster. Roivant Sciences has a diverse pipeline of drug candidates in various stages of development, including treatments for Alzheimer's disease, Parkinson's disease, and schizophrenia.
Learn more about Roivant Sciences
Size
800 employees
Market Cap
$5.6 billion
Industry
Pharmaceuticals & Biotech
Founded
2014
* Ladders Estimates

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