Senior Director, Regulatory Affairs Strategy

Reporting to the SVP, Global Regulatory Affairs, the Senior Director will be responsible for developing and implementing global regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. This individual will provide regulatory leadership and a sense of urgency to cross-functional teams responsible for global programs and ensure effective communication with business partners and representatives of the US Food and Drug Administration/EMA and other Health Authorities worldwide.

This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including, but not limited to):

• Provide regulatory strategic leadership for Rilonacept drug development projects and life cycle management (LCM), including but not limited, to regulatory submissions to EMA and other Health Authorities worldwide, health authority interactions, and other regulatory requirements in line with corporate objectives and timelines
• Provide regulatory strategic leadership for drug development projects, including but not limited, to health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives and timelines
• Serve as an influential and well-respected spokesperson with staff at FDA/EMA and other Health Authorities, including leading meetings and preparations to facilitate expedited approval of original applications and supplements
• Provide de-risking development strategies and evaluating opportunities to accelerate development in a fast-paced environment
• Provide leadership, and contribute hands on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA/EMA and other Health Authorities worldwide in support of INDs, BLAs, MAAs, DMFs, CTRs/CTAs, IMPDs, PIPs, PAERs, amendments, safety reports, and annual updates
• Interpret and communicate regulatory expectations to internal and external stakeholders in order to execute program objectives in compliance with applicable regulations
• Contribute to the strategic leadership and development of policies, procedures and best practices commensurate with the requirements of a rapidly growing company

Qualifications:

• Requires a minimum of 10 years of experience in Regulatory Affairs within the bio pharmaceutical industry
• Master's Degree required
• PharmD or PhD preferred
• Strong knowledge of FDA and EU regulations
• Prior experience with FDA and EMA required, and success with filing BLAs/NDAs/MAAs desired. Experience with both early and late-stage drug development desired
• Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities
• Experience required with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, briefing packages, pediatric study plans and documents for other regulatory submissions
• Experience interacting directly with the FDA/EMA and other health authorities desired
• Strong leadership and communication skills and experience in working with multiple functional areas in a matrixed team environment required
• Experience with biologics drug development is desirable; experience in immunology/inflammation is a plus
• Familiar with eCTD, e-publishing systems for preparing regulatory submissions a plus
• Strategic thinker who can balance near term objectives with long term goals and outcomes
• Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience
• Ability to thrive in a collaborative and fast-paced team environment
• Strong commitment to compliance and ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 10%

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.