Director of Regulatory Affairs

Location – Hybrid Position Greater Boston

Our client is a commercial-stage pharmaceutical company committed to developing and commercializing therapeutics to help improve patients’ lives with severe eye disorders. With approved products and a robust pipeline, this is the perfect time to join this growing team.

Overview: In this high visibility role, you will report directly to the Chief Regulatory Officer. The Director of Regulatory Affairs Strategy will be responsible, in alignment with the CRO, for assisting in designing regulatory strategies during the development and life-cycle management of assigned programs. In this role, you will act as the primary regulatory liaison with the US FDA and work closely with the Global Clinical Research Organization and ex-US consulting firms to coordinate the execution of established regulatory submission plans.

Responsibilities:

• Assists the Chief Regulatory Officer (CRO) in designing and implementing regulatory strategy plans for assigned products/projects, form development, and throughout the life cycle of the dossier/product.
• Working closely and collaboratively with Regulatory Operations and Regulatory CMC, this is a ‘hands-on’ position where an individual must be versatile and capable of managing the operational workload and strategy execution.
• Interfaces directly with the US FDA and acts as primary liaison.
• Authoring health authority responses alongside subject matter experts and submission deliverables.
• Manage the routine maintenance of open regulatory applications, emphasizing high-quality, timely submissions to Regulatory Agencies, submission activities initial IND, NDA.
• Coordinates with Regulatory Operations and Regulatory CMC.
• Works closely with CRO to prepare and facilitate informal and formal regulatory meetings aligned with established regulatory and development strategies.
• Participates actively and assists CRO in the Advertising and Promotional Review and submission (FDA 2253) process.
• Works with functional groups to ensure documents adequately support the established regulatory strategies.
• With minimal supervision, manage routine development and post-approval regulatory activities.
• Maintains working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
• Archives and maintains regulatory submissions, correspondence, and other regulatory documents in compliance with regulatory requirements and SOPs.

Qualifications:

• BA/BS degree in life sciences discipline, Master of Sciences in Regulatory Affairs is highly desirable.
• At least 5-7 years of pharmaceutical industry experience, of which at least 4 years of Regulatory Affairs strategy drug development experience.
• Experience and knowledge in preparation of INDs, NDAs, and supportive amendments or supplements.
• Working knowledge of eCTD elements and structure, ICH standards, and submission requirements.
• Experience with small molecules and drug-led-device combination products preferred.
• Ophthalmic Therapeutic experience preferred
• Experience in Clinical Trial Authorization Applications in Canada, EU, and other regions/countries is preferred.
• Experience with eCTD (US and ex-US) and using Regulatory Information Management System preferred.
• Strong communication and regulatory writing skills.
• Proficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates.
• Ability to balance multiple tasks to meet priorities and timelines.

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