60%

• Manage all aspects of regulatory submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements.
• Lead functional groups across the organization in the development of relevant data to complete regulatory submissions.
• Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelines.
• Manage activities to maintain regulatory filings including planning and preparing BLA amendments, IND/CTA amendments, annual reports, DSURs etc.
• Lead the development of briefing documents for formal regulatory meetings.
• Provide regulatory guidance to cross-functional teams.
• Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Initiate and contribute to local process improvements which impact various functional groups
• Develop and maintain cooperative relationships as the point of contact with partners and regulatory health authorities
• Contribute to the development of ex-US regulatory submissions

30%

• Manage the development of regulatory processes to manage pre-approval compliance activities.
• Support the development of regulatory processes for submission planning and management.

10%

• Other projects and duties may be required

• BS in Life/Health Sciences required, graduate degree preferred.
• Minimum 4-6 years experience in Regulatory Affairs or 2-4 with a MS/PhD.
• Pharmaceutical or related environment with biologics experience preferred.
• Working knowledge of all FDA requirements pertaining to submission of regulatory documents
• Demonstrated ability to coordinate submissions independently in a time intensive situation

• Knowledge of the drug development process, with a focus on IND/CTA and BLA/MAA processes.
• Demonstrated experience in preparing IND and/or BLA submissions is required.
• Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents.
• Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as FDA, international, and, if applicable, local regulations.
• Excellent interpersonal communication and organizational skills
• Possesses strong critical and logical thinking

• Demonstrated strong writing and communication skills
• Strong attention to detail
• Demonstrated ability to work both independently and in a team environment
• Demonstrated ability to multi-task, manage competing priorities (i.e. working on two or more projects with overlapping timelines)
• Highly flexible, adaptable, and experienced in a fast-paced environment
• Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
• Demonstrates excellent verbal and written communication skills.

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