The Regulatory Strategy Senior Scientist is responsible for submitting routine regulatory submissions to the EMA and other Health Authorities. This will include preparing, reviewing and submitting high quality content and delivering within company timelines and in accordance with regulatory guidelines and applicable legislation. Submissions include initial CTA’s, GMO applications, briefing documents, amendments, annual reports, DSURs and any additional documents, as needed. The Regulatory Strategy Senior Scientist will need to interact effectively with cross-functional team members in order to coordinate the necessary documentation required for submissions, ensuring that timelines are met. The role will also work with the relevant Regulatory Leads to obtain approval of regulatory submissions through interactive communication with the EMA and other Health Authorities for investigational and/or marketed drug products. This role will work with Regulatory Lead to develop regulatory strategy on preclinical, clinical and/or CMC issues or coordinate and support the team in planning and preparation for Regulatory meetings or teleconferences.
Job Function and Description
• Coordinate activities to initiate and maintain regulatory filings, including planning and preparing initial CTAs, GMO applications and any subsequent amendments, annual reports and DSURs, as appropriate.
• Interact with functional groups across the organization in the development of relevant data to complete regulatory submissions.
• Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelines.
• Support the development of regulatory processes to manage developmental and post-approval compliance activities.
• Support the development of regulatory processes for submission planning and management.
• Other projects and duties as may be required to support business needs.
• Other projects and duties as may be required
Education and Experience Requirements
• BSc in Life/Health Sciences required; advanced degree preferred.
• Typically has an advanced degree in a scientific discipline and 3+ years of related experience; may also have a Bachelors degree with 5+ years of related experience. Individual experience may vary based on skillset and expertise.
• Experience in rare diseases, gene therapy, and/or biologics preferred.
• Working knowledge of EU and UK 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, Scientific Advice etc.).
• Experience of directly working with EU/UK national regulatory agencies and leading agency meetings.
• Experience working with novel drug therapies and orphan products is preferred but not essential.
Key Skills, Abilities, and Competencies
• Excellent interpersonal communication and organizational skills.
• Possesses strong critical and logical thinking.
• Demonstrated strong writing and communication skills with excellent verbal and written communication.
• 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
• Ability to follow scientific arguments, identify regulatory scientific data needs, and with support solve regulatory issues.
• 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%)
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.