Eu Regulatory Affairs Lead - London, United Kingdom - Spark Therapeutics

Description

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.


Primary Duties

Job Function and Description

• Manage all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements.
• Lead crossfunctional groups across the organization in the development of relevant data to complete postapproval and developmental regulatory submissions.
• Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelines.
• 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
• 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 multitask, manage competing priorities (i.e. working on two or more projects with overlapping timelines).
• Highly flexible, adaptable, and experienced in a fastpaced 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
• Problemsolving 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.