The Regulatory Strategy Leadwill support developmental and post-approval projects as assigned. The lead provides strategic input to project teams for assigned programs. This role is responsible for leading/managing relevant submissions including but not limited toIND submissions briefing documents for agency interactions, orphan drug applications, and marketing authorization applications. The Regulatory Strategy Lead works to coordinate interactions with FDA and other Health Authorities, to validate regulatory strategy, and to facilitate planning of regulatory agency meetings and interactions.The Regulatory Strategy Lead will also 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.
- 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 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 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 ex-US regulatory submissions
- Manage and continuously improve the development of regulatory processes to manage pre-approval and post-approval compliance activities.
- Support the development of regulatory processes for submission planning and management.
- Develop and mentor junior regulatory team members.
Education and Experience Requirements
- Other projects and duties may be required
Key Skills, Abilities, and Competencies
- BS in Life/Health Sciences required, graduate degree preferred.
- Typically has an advanced degree in a scientific discipline and 4-6 years of related experience. May also have a Bachelor’s degree with significant related experience - generally 6-8 years. Individual experience may vary based on skillset and expertise.
- Pharmaceutical or related environment with biologics experience preferred.
- Working knowledge of FDA requirements pertaining to submission of regulatory documents.
- Experience of directly working with the FDA and leading agency meetings.
- Demonstrated ability to coordinate submissions independently in a time intensive situation.
Complexity and Problem Solving
- Knowledge of the drug development process.
- Familiarity with gene therapy is desirable.
- Demonstrated experience in preparing BLA amendments is preferred.
- 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.
- 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.
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.
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. Nearest Major Market:
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.