Regulatory Affairs Lead

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 unlock the power of gene therapy to accelerate healthcare transformation.

We don’t follow footsteps. We create the path.

**Primary Duties**

The Director, Regulatory Affairs will collaborate with other Regulatory Affairs & Patient Safety leaders as necessary to support the build of appropriate EU/International infrastructure relevant for developing regulatory policy and intelligence activities in the EU/International region.

**Responsibilities**
- Lead interactions with regulatory agencies in the given region at both national and central level and lead internal teams in navigating such interactions.
- Serve as a resource for EU/International knowledge for the global clinical development organization.
- Monitor emerging legislation and guidance in the given region and contribute to ensuring company-level awareness and compliance (where appropriate).
- Serve as Spark regulatory representative for the assigned program(s).
- Lead the regulatory submissions (ODDs, PIPs, CTAs etc.) relevant to assigned programs, in accordance with submission and approval requirements. Lead functional groups across the organization in the development of relevant data to complete regulatory submissions.
- Provide regulatory input to market access strategy and HTA plans and submissions in the EU/International region.
- Ensure QP requirements and local regulatory requirements are fulfilled for each country as necessary.
- Respond to objections/questions issued by Regulatory Authorities/Agencies.
- Lead Spark response to objections/questions issued by EU/International Regulatory Authorities/Agencies.
- Lead the preparation, submission and follow-up of Orphan Drug Applications, Pediatric Study Plans, Pediatric Investigational Plans, etc.
- Report adverse events and other unanticipated problems to EU regulatory agencies and internal stakeholders.
- Responsible for accuracy and content of communications
- Lead the preparation, review, and approval of compliant regulatory documents throughout the product lifecycle.
- Provide EU regulatory guidance to cross-functional teams for project and product lifecycle planning.
- Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and cross-functional teams.
- Work effectively with regulatory colleagues specializing in other functional areas to continuously improve regulatory systems, teamwork, and efficiency.
- Evaluate proposed nonclinical, clinical, and manufacturing changes for regulatory filing strategies.
- Manage and execute pre-approval and post-marketing compliance activities.
- Lead the development & implementation of EU regulatory policies, processes, systems, and SOPs and train key personnel on them.
- Contribute to the development of relevant networks with Roche colleagues to support the ongoing build of regulatory policy and intelligence activities/interactions for the EU/International region.
- Support and contribute to the development of Spark global regulatory strategies to advance Spark products through the regulatory review and approval process globally.
- Actively contribute to the development and implementation of regulatory processes for multi-country trials.
- Other program-related tasks and duties as may be required.

**Education and Experience Requirements**
- Degree in life science, e.g., Pharmacy, Biology or Chemistry required. PhD or other advanced scientific degrees strongly preferred.
- Generally, has 10+ years related experience (e.g., healthcare, and/or clinical research experience), with at least 8 years of direct regulatory experience.
- Experience of directly working with the EMA and national regulatory agencies and leading agency meetings face to face.
- Experience of bringing a product through EU approval is a distinct advantage.
- Experience working with novel drug therapies and orphan product is preferred.
- Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as EMA, FDA, international, and, if applicable, local regulations.

**Key Skills, Abilities, and Competencies**
- Ability to negotiate and concisely express clear positions to stakeholders at all levels.
- Excellent written and verbal communication skills.
- Thorough knowledge of the drug development process, with a focus on CTA and MAA/NDA/BLA processes.
- Excellent writing skills with an ability to write detailed information for submissions.
- Excellent ability to read, analyze and interpret technical documents, technical procedures and government regulations.
- Prepare and deliver effective presentations for external and internal audiences.
- Knowledge of computers and appropriate software packages. Experience with electronic submissions preferred.
- Ability to h