The Regulatory Policy Sr. Specialist is a critical member of the newly-established regulatory policy function at Spark. They will provide strategic regulatory policy and intelligence support to advance Spark’s development and business priorities and contribute to the growth of Spark’s regulatory policy presence and expansion of regulatory intelligence capabilities.
They will be responsible for:
- Coordinating regulatory policy activities across multiple disease areas and disciplines with the goal of shaping and influencing the regulatory framework for advanced therapies
- Identifying, analyzing, documenting, compiling, and communicating regulatory intelligence
- Under the supervision of the regulatory policy leader, working in close coordination with Spark subject matter experts to contribute to the development and implementation of regulatory policy strategies
- Supporting in preparation of regulatory and advocacy positions and facilitating external engagement, as appropriate, on key topics of interest
- Developing and maintaining an up-to-date understanding of the global regulatory landscape applicable to Spark’s portfolio and platform
- Collaborating across regulatory affairs functions (CMC, strategy etc.) on execution of regulatory policy and intelligence activities
- Contributing to increasing education and awareness of policy topics across Spark teams
% of Time
Job Function and Description
- Coordinate regulatory policy activities across cross-functional groups e.g., policy documents, commenting exercises, trade association participation and activities
- Facilitate strategic development of regulatory policy at Spark via identification and development of Spark’s policy priorities, advocacy positions and external participation
- Actively monitor the external regulatory environment across global health authorities, competitor programs and relevant scientific developments, with the goal of developing and communicating strategic insights of value to Spark
- Analyze and summarize new and emerging regulatory developments relevant to Spark’s areas of interest
- Attend key conferences and events as assigned, and create event reports with key insights and learnings
- Maintenance of regulatory policy and intelligence materials and document repository
- Coordination of and contribution to relevant communication materials
Education and Experience Requirements
- Organizational/ project management support of internal policy meetings and external policy participation
Key Skills, Abilities, and Competencies
- Bachelor’s degree in life sciences or public policy required
- Advanced degree in life sciences, law, public policy, or related field preferred
- Minimum 3-5 years professional experience
- Prior experience in regulatory policy and intelligence or at a regulatory agency preferred, alternately experience as a policy analyst/consultant or equivalent roles in the pharmaceutical industry will be considered
- Working knowledge of regulatory frameworks (at minimum US, US+ Europe preferred)
- Ability to work across matrix environments
- Excellent written and verbal communication skills
- Familiarity with advanced therapies (cell and gene therapies) or other non-traditional pharmaceutical modalities a plus
Complexity and Problem Solving
- Self-starter with the ability to work independently on assigned tasks
- Sharp analytical and critical thinking skills, attention to detail. Ability to synthesize complex information and create audience-appropriate messaging
- Ability to prioritize and manage multiple projects and workstreams simultaneously
- Comfortable with ambiguity and executing on abstract ideas, responsive to changing priorities and an evolving external regulatory environment
- Collaborative spirit and excellent people skills
- Scientific curiosity, active interest in developing knowledge of advanced therapies
Internal and External Contacts
- Ability to build productive working relationships internally and externally.
- Must be comfortable in the fast-paced, biotech start-up environment and interact with multi-disciplinary research and development teams at Spark.
- Works on real-time analysis of information from numerous sources and exhibits independent ability to synthesize complex material into key insights
- Exercises judgment within defined procedures and practices to determine appropriate action.
This role is:
- accountable to Spark’s regulatory policy leader
- works closely with all functions across regulatory affairs and key policy contacts across legal, government affairs, pricing and reimbursement and communications
- interacts regularly with subject matter experts across Spark
Other Job Requirements
Travel may be required for participation in relevant conferences, external meetings, and policy events (10-15%)
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.
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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.