Job Details

Overview 
Looking for substantial experience planning and managing regulatory authority submissions. Will independently with limited supervision manage multiple clinical programs and contribute to the execution of major submissions and responses to regulatory authorities related to IND/NDA submissions and amendments, support preparation of briefing packages for FDA meetings, and support the preparation and submission of routine regulatory documents such as Annual Reports/DSURs, Investigator Packages, and SUSARs. The Senior Associate will represent Regulatory Affairs on cross-functional teams, working closely with other team members to support corporate and departmental objectives. An important aspect of this role is the planning and management of submissions. Attention to detail in written correspondence, in the maintenance of regulatory files, and ability to work with diverse internal and external stakeholders are also important factors for success in this role.
Specific Responsibilities 

• Responsible for submission planning, oversight of planning of IND related activities like Annual reports, Orphan drug reports, DSUR and other CTA activities for on-going study or study start-ups
• Managing the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.
• Prepares routine IND and CTA amendments, for example, Annual Reports/DSURs, Investigator Packages, and SUSARs.
• Independently, under limited supervision manages Vendors / CROs for planning and tracking of source documents to ensure high-quality IND, IND amendments, CTA, EU-CTR submissions are delivered in timely manner.
• Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval and commercialization).
• Works with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
• Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics.
• Independently manages tracker for submissions across the multiple products.
• Maintains logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies.
• Prepares templates or shells for specific submissions based on company standards.
• Prepare and compile effective presentations for external and internal audiences as needed.
• Other duties as assigned.

Education and Qualifications

• BS degree required; advanced degree (PharmD, PhD, Master’s) preferred. Strong scientific or research background, with a focus in pharmacy, chemistry, or biology, preferred (or relevant experience).
• Minimum 8 years’ experience in regulatory affairs or a related function in drug/biologic development.
• Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format a plus.
• Understanding of US, and Ex-US including international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.
• Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
• High attention to detail and accuracy.
• High level of motivation and proactiveness required to engage in both in-person and remote team members.
• Excellent interpersonal, verbal and written communication skills.
• Ability to work independently with minimal supervision or direction
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities