Senior Manager, Regulatory Affairs Strategy - Oncology

Role Summary

The Senior Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.

Responsibilities

• Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
• Assist in coordination and preparation for Agency meetings and associated briefing document preparation
• Manages and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
• Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
• Perform research to support the development of regulatory strategy for the assigned clinical development program
• Maintains knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed
• Exercise discretion and independent judgment in the performance of the duties described above

Qualifications

• Required: MD, Ph.D. or PharmD degree and a minimum of 5 years of pharmaceutical industry experience, with at least 3 years of regulatory experience
• Preferred: Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
• Preferred: Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations
• Preferred: High attention to detail; ability to coordinate and prioritize assigned projects according to company goals
• Preferred: Strong interpersonal skills both written and verbal

Skills

• Regulatory strategy development
• Regulatory submissions management (INDs/CTAs, amendments, information requests, Orphan drug applications, annual reports, Investigator’s Brochure)
• Agency communications and briefing document preparation
• Regulatory intelligence and guidance interpretation
• Cross-functional collaboration and project management

Education

• MD, Ph.D., or PharmD required

Additional Requirements

• No additional travel or physical demands specified as essential in the provided description