This person will be leading the strategy both across US and EU for their emerging Ph II program and also devising the pediatric planning as they approach this step. As such, they are looking for someone who is confident in engaging with conversations with health authorities and keen to further their career as a strategist. The company is extraordinarily well funded with also partnership programs with large pharma.
What can this company offer you:
- High exposure to senior leadership
- Opportunities across early development and global regulatory leadership on Ph III planning and strategy
- 90% monthly premiums covered
- Commuter Benefits
- 401K
- FSA
- Flexible Time Off
- Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements and define timelines to ensure on-time delivery of high-quality, compliant, accurate and complete regulatory submissions
- Support regulatory and compliance initiatives including the development, implementation and maintenance of company systems, processes, policies, and procedures
- Contribute to and participate in internal and external education and training activities
- This position may manage the activities of other regulatory affairs staff or contract regulatory support
Preferred Experience and Education:
· Bachelor’s degree in a scientific field preferred
· Minimum 8 years in the pharmaceutical or biotech industry experience of direct experience in the pharmaceutical industry managing regulatory strategy related to product development and commercialization
· A background in immunology and small molecule products is preferred
· Experience with early development is preferred
· Strong leadership and interpersonal skills with reputation for collaboration with colleagues
· Must be willing to be hands-on, contributing to submissions and timeline management
· Expert understanding of the content and submission requirements for US and international clinical trial applications (INDs, CTAs), and marketing applications (NDAs, MAAs) as well as amendments and supplements to submissions
· Experience leading, writing and submitting major regulatory submissions such as IND, CTA, NDA/MAA as well as submissions supporting these applications including but not limited to designation requests, health authority responses, and annual updates through all phases of clinical development