Our client is a clinical stage pharmaceutical company which is developing novel therapeutics for the treatment of cancer. They are seeking a Regulatory Affairs Associate Director (or Sr. Manager) to contribute to regulatory strategies and support clinical development activities such as clinical trial activation, IND and CTA submissions, and health authority interactions. You will closely interact with multiple functions across the organization and external CROs while leading regulatory initiatives. Now is an exciting time to join this growing company to help advance the company’s product development pipeline.
Responsibilities:
- Contribute to the development of global regulatory strategy regarding overall development plans
- Lead regulatory submission planning and coordination, including the preparation of regulatory submission documents in accordance with regulatory agency requirements, standards, and corporate practices
- Responsible for maintaining active IND/CTAs, including timely coordination of responses to health authority questions/comments
- Represent the regulatory affairs function in study teams to provide regulatory support and advice
- Interact with corporate partners, CROs, and vendors regarding various regulatory matters
- Provide support for regulatory interactions, including health authority meetings and teleconferences
- Troubleshoot situations as needed and understand when problems need to be escalated
- Draft or modify applicable SOPs and/or other written practices relating to the regulatory affairs function
Knowledge and Skills:
- Bachelor’s degree required; RAC Certification a plus
- 7+ years’ experience in pharmaceuticals or biotech with 5+ years’ experience in regulatory affairs
- Experience with clinical trial submissions and maintenance (IND/CTA), including tracking timelines and responding to health authority questions/requests
- Experience with NDA/MAA submissions a plus
- Knowledge of global clinical trial regulatory requirements
- Comfortable with developing regulatory strategies
- Oncology development experience highly desired
- Excellent written and oral communication capabilities, with strong attention to detail
- Highly organized, independent, and self-motivated with ability to multi-task
- Strong time and project management competency, with the ability to create timelines and meet deadlines
- Demonstrated ability to work within a cross-functional team and in a matrix environment
- High degree of proficiency with MS Office applications