Senior Manager (or) Associate Director Regulatory Affairs
We are looking for a Senior Manager / Assoc Director Regulatory Affairs professional to join a clinical stage biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics to treat patients world-wide. My client has five clinical-stage development programs focused on a variety of cognitive impairments and compulsive disorders. You will be coordinating the drafting, editing and preparation of regulatory submissions. The company has an average employee tenure of 8 years; along with a deep pipeline and a proprietary research platform.
Responsibilities:
- Ensuring the content and accuracy of regulatory fillings
- Overseeing and ensuring that the regulatory files and systems are maintained in accordance with department procedures, compliance standards, laws, and regulations
- Interacting with domestic and foreign regulatory agencies on assigned projects
- Serving as the regulatory representative at project meetings and interacting with personnel from corporate partners in order to achieve common goals
- Negotiating, interacting with, and supervising the activities of contract manufacturing organizations (CMO’s) in the preparation of regulatory submissions
- Managing regulatory tasks within time and budgets for approved project plans
- Communicating project status and issues
Knowledge and Skills:
- BS/MS degree in a life science or related field
- Minimum of 5-7 years’ experience in regulatory affairs; additional experience working in a biopharmaceutical capacity with a minimum of 2 years spent in drug development
- Experience in the drug development process and with regulatory guidelines
- Drug development process knowledge
- Regulatory guidelines knowledge
- Demonstrated ability to lead and manage projects
- Strong analytical and problem solving skills