Head, Regulatory Affairs - United States, United Kingdom, Switzerland
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- We are seeking a Regulatory leader to drive the overall success of our programs.
- The Regulatory strategist will build and lead the regulatory capabilities for our key programs.
- The individual will be responsible for all regulatory interactions and activities, including driving meetings, communications and submissions to US and EU agencies.
- The individual will work collaboratively with the leadership and project teams to deliver on program goals / objectives, and to support all preclinical and clinical studies.
- This is an exciting and interdisciplinary role for a highly qualified and motivated individual.
- The successful candidate will be a confident leader, with attention to detail and significant prior success in regulatory in the preclinical and early clinical stage programs in the biotechnology industry. The successful candidate will also have a solid scientific understanding the biology of genome technologies and multiple modes of therapeutics including cell based, viral and gene therapy, and will be ready to understand and create regulatory pathways for novel genomic therapeutics.
- Finally, the successful candidate will have a deep knowledge of all aspects regulations and practices in both the US and EU.
- We are seeking someone with a sense of urgency for developing important new medicines for devastating diseases and who is interested in forging new and uncharted paths to patients for the exciting company technology.
- Accountable for all regulatory activities
- Work collaboratively with the project teams to create a plan for all regulatory interactions, including driving novel thinking and pathways for gene editing products
- Understand and drive regulatory strategy for all programs within the company.
- In collaboration with the project teams and discovery scientists, establish early FDA/EMA/MHRA interactions and credibility, submitting briefing books and driving interactions
- Ensure high quality and timely regulatory submissions
- Coordinate with relevant functional groups to ensure timely execution of regulatory activities, including anticipating and identifying risks, mitigations and contingencies, and supporting timely action plans and issue resolution
- Ensure effective communication within, and across the Company to align regulatory activities with corporate strategy, and ensure effective program execution
- Foster a culture of ownership and accountability, including; continuous benchmarking, evaluation, recognition and continuous improvement
- Partner with finance and functional leaders to develop budgets, including; capability and capacity needs, and monitors spend against budgets; develops scenario planning for decision-making
- Ensure compliance with all applicable regulations
- Ensure internal teams are driving compliance within their functions
- Build relationships with key stakeholders both at our company Therapeutics and at any Alliance Partners to ensure high quality decision making
- 15 years experience in life sciences industry, with 5+ years of demonstrated regulatory strategy and key submissions (IND, NDA, BLA etc)
- Outstanding leadership and management skills with an integrated view of business and scientific issues, and demonstrated passion for creating new medicines
- Advanced degree in the life sciences (PhD or MBA)
- Excellent verbal and written communication skills
- Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively
- Proficient in MS Office suite
- Familiar with cell and molecular biology techniques
- High degree of energy, accuracy and attention to detail, and a passion for delivering important new medicines to patients with devastating diseases
- Experience leading gene editing or gene therapy programs
- Business degree or extensive business training
- Relationship Building – Builds and maintains productive working relationships across a diverse spectrum of people
- Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related
- Job Knowledge – Achieves and maintains technical and professional proficiency related to current job position and areas of expertise
- Results Oriented – Drives issues to closure and gets the job done
- Product Creation - Effective and efficient discovery strategies that will enable us to achieve ~1 IND/year
- Strategic Thinking – The ability to develop strategies and goals that recognize business issues, opportunities, and environment
- Integrity and Trust – Acts ethically and gains the trust and respect of others