Senior Associate / Manager, Regulatory Affairs
The Senior Associate/Manager, Regulatory Affairs is responsible for providing support in the planning and preparation of regulatory submissions and the general execution of Regulatory Affairs (RA) research support responsibilities. This includes assisting the regulatory strategy leadership and management of the company’s development programs and will work closely with Clinical, Research & Development, Quality and other disciplines to ensure an effective linkage of regulatory strategy and requirements, and the timely submission and approval of regulatory filings.
- Review of clinical site regulatory documents intended for site approval and maintenance.
- Interface with project team members and functional departmental representatives to obtain documentation and establish timelines to ensure that complete and accurate submissions are prepared according to plan.
- Plan, compile, and submit regulatory documents for IND and other applications, including initial submissions, amendments, and meeting materials to the FDA or other Regulatory Authorities.
- QC review of IND submissions and CTA submission packages, amendments, notifications, etc.
- Maintain regulatory databases including submissions and regulatory authority correspondence to meet regulatory compliance requirements.
- Support the preparation and development of responses to incoming FDA or other Regulatory Authority queries
- Prepare or assist in the preparation of various regulatory documents.
- Participate in the development and review of departmental SOPs.
- Assist with or execute the electronic publication of documents for submission to the FDA as needed.
- Facilitate cross-functional writing of nonclinical reports, IND/CTA sections, protocols, etc. supporting regulatory submissions etc., as well as write and edit documents as needed.
- Assume responsibility for IND maintenance, including routine and more substantial IND amendments.
- Support communication with the relevant personnel at the FDA or other Health Authority, as required.
- Support the preparation and conduct of Agency meetings as necessary, including preparation and coordination of meeting planning and materials.
- Support late stage development, including supporting the development of NDA/MAA and other global filing plans.
- Coordinate with Regulatory Operations in the generation of documents suitable for electronic filings.
- BA/BS/MS degree in Chemistry/Biology/Engineering or a related field
- >5 years of experience in a biotech/pharmaceutical industry
- Regulatory Affairs/Operations Experience including compiling IND, NDA, and other submissions, strongly preferred.
- RAC or other Regulatory Affairs educational course work in lieu of direct regulatory experience
- Strong attention to detail and the ability to manage multiple tasks.
- Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Ability to independently solve problems and work cross-culturally.
- Ability to represent RA at team meetings.
- Demonstrated ability to work as a team player with multi-disciplinary project teams.
- Excellent written and communication skills.
- Software knowledge of Microsoft Office Suite, Adobe Acrobat, SharePoint required.
- Knowledge of eCTD format and regulatory submission requirements desirable.
- Experience using or supporting electronic document management systems a plus.
Equal Employment Opportunity/M/F/disability/protected veteran status