The Regulatory Strategy Lead will support developmental and post-approval projects as assigned. The lead provides strategic input to project teams for assigned programs.  This role is responsible for managing IND submissions, marketing application and post-approval submissions, as appropriate.  The Regulatory Strategy Lead works to coordinate interactions with FDA and other Health Authorities to validate regulatory strategy and facilitate planning of regulatory agency meetings and interactions.

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 relevant data to complete developmental and 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 MAAs, BLA amendments, IND/CTA amendments, annual reports, 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 compliance activities.
• Support the development of regulatory processes for submission planning and management.
• Develop and mentor junior regulatory team members.
• Other projects and duties may be required
• Domestic and international travel as required (~10%)
• This a hybrid role with 3 days in-office

Education and Experience Requirements

• BS in Life/Health Sciences required, graduate degree preferred.
• Typically has an advanced degree in a scientific discipline and minimum 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
• Demonstrated ability to coordinate submissions independently in a time intensive situation

Key Skills, Abilities, and Competencies

• 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

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 $117,700 to $176,500.