The Regulatory Strategy Lead will provide strategic input and leadership to project teams in support of developmental and post-approval projects as assigned. This role is responsible for leading and/or managing relevant submissions including, but not limited to, CTA submissions, briefing documents for agency interactions, orphan drug applications, paediatric investigation plans and marketing authorization applications. The Regulatory Strategy Lead will serve as the primary interface with the EMA and other international Health Authorities for assigned projects and will leverage their knowledge of the relevant agencies/regulations to validate regulatory strategy and facilitate planning of regulatory agency meetings and interactions. The Regulatory Strategy Lead will be responsible for recommending strategies for earliest possible approvals 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.
Job Function and Description
• 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 relevant data to complete post-approval and developmental regulatory submissions.
• Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelines.
• Manage activities to maintain regulatory filings including planning and preparing IND/CTA applications and amendments, annual reports, MAAs, BLA amendments, PBRERs, DSURs etc.
• Lead the development of briefing documents for formal regulatory meetings.
• Provide regulatory guidance to project teams.
• Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Initiate and contribute to local process improvements which impact various functional groups
• Develop and maintain cooperative relationships as the point of contact with partners and regulatory health authorities
• Contribute to the development of EU/International regulatory submissions
• Manage and continuously improve the development of regulatory processes to support compliance activities.
• Support the development of regulatory processes for submission planning and management.
• Develop and mentor junior regulatory team members.
•Other projects and duties as may be required.
Education and Experience Requirements
• BSc in Life/Health Sciences required; graduate degree preferred.
• Typically has an advanced degree in a scientific discipline and 6+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.
• Pharmaceutical or related environment with biologics experience preferred.
• Working knowledge of EU regulatory requirements pertaining to submission of regulatory documents.
• Demonstrated ability to coordinate submissions independently in a time intensive situation
• Proven track record of supporting EU regulatory applications (e.g. Clinical Trial Applications, Marketing Authorization Applications, Pediatric Investigational Plans, and Scientific Advice).
• Experience of directly working with the EMA and EU/UK national regulatory agencies and leading agency meetings.
• Comprehensive understanding of the different regulatory pathways and market planning across key regions.
• Experience working with novel drug therapies and orphan products is preferred but not essential.
Key Skills, Abilities, and Competencies
• Knowledge of the drug development process.
• Familiarity with gene therapy is desirable.
• Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents.
• Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as FDA, 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 and with external contacts. Complexity and Problem Solving
• Problem-solving agility; ability to exercise judgment independently;
• Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues;
• Works on problems of diverse scope, where analysis of data evaluation and presentation are required;
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Internal and External Contacts
•Internal collaboration across functions as well as external interactions with regulatory authorities and consultants as necessary to perform the role.
Other Job Requirements
• Domestic and international travel as required (~10%)
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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 challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.Learn more about Spark Therapeutics and view other openings.