Manager - Associate Director RA Strategy
Company Summary:
My client, a biopharmaceutical company focusing on fighting rare diseases is looking to add a Regulatory professional to their team - they are open to hiring at the Manager level through Associate Director! This role will be hybrid based in Paramus, New Jersey requiring 2 days per week onsite.
This Regulatory professional (who could be a Manager - Associate Director) will be responsible for:
- Acting as liaison to the FDA and providing regulatory strategic support and guidance across all functions
- Identifying potential issues/gaps and proposing creative risk mitigation strategies
- Communicating regulatory requirements to ensure compliance with applicable regulations and guidelines
- Supporting and/or leading the planning and execution of major and life-cycle management maintenance submissions and responses to regulatory authorities related to INDs, NDAs, etc.
- Interpreting and communication health authority correspondence effectively to senior leadership and project teams
This Regulatory professional (who could be a Manager - Associate Director) should have the following qualifications:
- Bachelor's degree with 5 or more years of regulatory experience in biotech/pharma industry including 3 or more years of new drug strategy/submissions
- Knowledge of prescription drug laws, ICH guidelines, regulations and health authority guidelines
- Experience in oncology/rare diseases is preferred
If you are interested in this position, please apply today and do not hesitate to contact me with any questions!