General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for European regulatory activities related to SAGE’s clinical development programs. The Director, Regulatory Affairs will be responsible for EU regulatory filings and interactions with EU agencies. This role will report to the SVP, Regulatory Affairs & Quality Assurance based in the US, with a dotted line to Sr. Medical Director, Europe.
Roles and Responsibilities
- Collaborate with US based regulatory lead and program team to execute on corporate regulatory strategy in Europe.
- Provide strategic guidance regarding regulatory requirements for European clinical development and registration of pharmaceuticals.
- Act as the primary contact for European health authorities on behalf of the Company.
- Provide oversight of all correspondence, including review and approval of correspondence with local health authorities by contract research organizations. Ensure archival of all correspondence.
- Coordinate and participate in meetings with European health authorities along with US based colleagues.
- Compile, review and manage the submission and maintenance of clinical trial applications, amendments, Investigator Brochures and other study documentation to support clinical development in Europe.
- Compile, review and manage the submission and maintenance of marketing authorizations, working with the global regulatory team to harmonize with requirements in other countries.
- Compile, review, manage and gain approval for pediatric investigational plans.
- Actively work with global Company stakeholders to manage timelines, content of submissions and responses to health authority questions.
- Manage and ensure compliance with all reporting requirements, including expedited and periodic development safety reports.
- Manage contract staff and vendors as needed to support regulatory activities.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Specific requirements include but are not limited to:
- 8-12 years of experience in Regulatory Affairs related to development of pharmaceuticals, CNS experience preferred.
- Bachelor of Science in a scientific discipline, MS or PhD preferred.
- Prior experience in a global role working with US stakeholders.
- Excellent knowledge of European Clinical Trial Application requirements
- Strong knowledge of eCTD structure and European Marketing Authorisation Applications.
- Strong regulatory writing skills and use of Microsoft Word.
- Experience with coordinating/managing/presenting at European agency face to face meetings.
- Experience participating in scientific advice meetings.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication and presentation skills.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage