Responsible for strategic and operational regulatory input and support for collaboration with other project team members, including regulatory team members.
Contributes to the development of regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
Prepares and/or manages submissions that may be technically complex and require extensive interaction with departments outside of regulatory affairs.
Provide regulatory advice and information to cross-functional teams and to other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals.
Leads the drafting, review, and finalization of responses to queries from Regulatory Authorities
Maintains knowledge of regulatory requirements up to current date and communicates changes in regulatory information to other departments.
Education Qualifications
A degree in a life science, chemistry, or chemical engineering or closely related discipline with a graduate degree preferred
Experience
At least 10 years of experience in pharmaceutical regulatory affairs, that includes, but cannot be limited to, CMC regulatory affairs.