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Immunovant
2 months ago
100% remote workus national

Title: Senior Director CMC Regulatory Affairs

Location: Remote

Job Description:

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

Reporting to the Senior Vice President, Global Regulatory Affairs, this position is responsible for …

Key Responsibilities: 

  • Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure global CMC regulatory requirements and strategy are understood by project teams.

  • Play a hands-on role in planning, preparing, and coordinating CMC documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.

  • Partner and work very closely with internal and external cross-functional team members to ensure achievement of submission deadlines and timely approvals of CMC-related applications

  • Lead and support interactions with FDA and other Health Authorities for CMC-related topics.

  • Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables.

  • Maintain up-to-date knowledge and understanding of global regulatory requirements.

  • Initiate and contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives.

  • Provide hands-on leadership to the regulatory and manufacturing team in planning, preparing, and coordinating CMC documents submitted to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.

  • Ability to communicate with CMC management and leadership on CMC creative filing strategies, summarize regulatory strategy and associated risks in a collaborative manner.

  • Strong stakeholder partnership with Quality, project management, supply chain and CMC to enable open and robust discussions to achieve the best scientific decisions.

  • Communicate project updates and risks to senior management and stakeholders throughout the organization. Track regulatory commitments and deliverables.  Interact effectively and independently with consultants.

  • Ability to establish an integrated CMC regulatory strategy that anticipates risk, aligns with enterprise objectives, and secures cross-functional alignment across Technical Operations, Quality, and Program leadership.

  • Leadership across CMC strategy and supervision. Expected to manage the CMC team and contractors supporting work, along with coaching and mentoring of the staff.

Requirements:

  • Masters or PhD degree in a relevant scientific discipline, Advanced degree preferred

  • 12+ years of biopharmaceutical experience, which includes at least 6 years of direct experience in Regulatory Affairs CMC

  • Demonstrated, hands-on experience in biologics drug development, registration, and post-approval life cycle management in a global environment. Direct involvement with parenteral products, including drug-device combination development.

  • Comprehensive understanding of CMC product development with biologics and drug-device combinations and knowledge of applicable global regulations, guidance, and practices

  • Experience in the preparation and submission of global regulatory dossiers (including IND/CTA/NDA/BLA/MAA), briefing documents, and agency queries. Recent and relevant BLA filing experiences.

  • Prior experience leading interactions with global regulatory authorities on CMC-related issues

  • Strategic and analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines

  • Strong leadership in working with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations

  • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to erse internal and external audiences including executive leadership

  • Ability to thrive in a collaborative and fast-paced environment

Specialized knowledge, Licenses, etc.:

  • Results-oriented iniduals with a strong work ethic and ability to complete projects with minimal oversight; track record of successful IND, CTA, NDA/BLA, and MAA submissions

  • Knowledge of GxP, ICH, FDA, EMA and other global regulations and guidance

  • Attention-to-detail and an ability to balance analytical and critical-thinking skills to develop data-driven, strategically oriented regulatory proposals and documents

  • Strong experience leading regulatory CMC strategy and input for biologics and drug-device combination development programs

Work Environment:

  • Remote-based

  • Dynamic, interactive, fast-paced, and entrepreneurial environment

  • Domestic or international travel are required (10-20%)

Salary range for posting

$260,000—$295,000 USD

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.