Regulatory Affairs Diagnostic Strategy Lead

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. 

We don’t follow footsteps. We create the path.

Primary Duties

The Regulatory Diagnostic Lead will be the regulatory diagnostic subject matter expert at Spark and will work to lead and deliver on global diagnostic regulatory strategy as an integrated part of the global regulatory strategy for the Gene Therapy. The Regulatory Diagnostics Lead will support developmental and post-approval projects as assigned. The lead will provide strategic regulatory diagnostics input to project teams for assigned programs.  This role is responsible for leading/managing global regulatory plans to support a precision medicine approach (e.g. integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies. The Regulatory Diagnostic Lead works to lead interactions with FDA and other Regulatory Authorities, to validate regulatory diagnostic strategy, and to ensure compliance of diagnostic strategy programs with regulatory requirements for diagnostics and devices. The Regulatory Diagnostic Lead will provide global strategic input on key development documents including (but not limited to) clinical protocols, study reports, SRDs etc. The Lead will develop and/or contribute to global strategies to support planned submissions e.g. IDEs, INDs, CTAs, PMAs etc. and be responsible for ensuring compliance with applicable global and regional regulations e.g. IVDR. Provides guidance on planning, writing, review of key dossier documents for submissions globally. The Regulatory Diagnostic Lead will also be responsible for recommending strategies for earliest possible approvals of diagnostics and devices in support of clinical trials and marketing authorization applications, and will combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured and/or distributed to meet the required legislation in the target market.

Responsibilities

• Manage all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements. 
• Lead cross-functional groups across the organization in the development of global regulatory strategy to complete developmental and post-approval regulatory submissions. 
• Define contributions for submissions, communicate to functional contributors, and track delivery according to agreed timelines.
• Manage activities to maintain global regulatory filings including planning and preparing development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, IVDR, PMAs and labeling for drug and diagnostic products.
• Lead the development of briefing documents for formal regulatory meetings.
• Provide regulatory diagnostic guidance to project teams and external diagnostic vendors. 
• Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product and diagnostic lifecycle and develop solutions with other members of regulatory and related teams.  
• Develop and maintain cooperative relationships as the point of contact with partners and regulatory health authorities.
• Contribute to the development of global regulatory diagnostic submissions.

• Manage and continuously improve the development of regulatory processes to manage pre-approval and post-approval compliance activities.
• Support the development of regulatory diagnostic processes for submission planning and management.
• Initiate and contribute to local process improvements which impact various functional groups.
• Develop and mentor junior regulatory team members.

• Other projects and duties may be required.

Education and Experience Requirements

• BS in Life/Health Sciences required, graduate degree strongly preferred. 
• Typically has an advanced degree in a scientific discipline and 8+ years of related experience.  May also have a bachelor’s degree with significant related experience - generally 10+ years.   Individual experience may vary based on skillset and expertise.
• Direct device/diagnostic regulatory experience required.
• Working knowledge of FDA requirements pertaining to submission of regulatory documents.
• Experience of directly working with the FDA/other Regulatory Authorities and leading agency meetings. 
• Demonstrated ability to coordinate submissions independently in a time intensive situation.

Key Skills, Abilities, and Competencies

• Knowledge of the drug and device development process. 
• Familiarity with gene therapy is desirable.
• Demonstrated experience in preparing PMA/CE Marking applications is preferred.
• Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents, particularly for diagnostics and devices.
• Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs), ISO and ICH guidelines as well as FDA/EU IVDR, international, and, if applicable, local regulations. 
• Excellent interpersonal communication and organizational skills.
• Possesses strong critical and logical thinking.
• Demonstrated strong writing and communication skills.
• Strong attention to detail.
• Demonstrated ability to work both independently and in a team environment.
• Demonstrated ability to multi-task, manage competing priorities (i.e. working on two or more projects with overlapping timelines).
• Highly flexible, adaptable, and experienced in a fast-paced environment.
• Demonstrates the ability to establish and maintain good working relationships at all levels of the company, Roche Group and with external contacts.
• Domestic and international travel as required (~10%)

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.  The base salary range for this position is currently from $150,100 to $225,100.  

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.