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‚Äôs 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 Pharm D. degree with excellent written and verbal communication skills; minimum of 5 years of pharmaceutical industry experience, at least 3 of which should include regulatory experience
• Preferred: Good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
• Preferred: Interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations

Skills

• Regulatory strategy development
• Global regulatory submissions (INDs/CTAs, amendments, information requests, orphan drug applications, annual reports, Investigator‚Äôs Brochure)
• Agency meeting preparation and briefing documents
• Regulatory writing and responses to agency queries
• Cross-functional collaboration and project coordination
• Regulatory knowledge up to date with current requirements

Education

• MD, Ph.D. or Pharm D. degree

Additional Requirements

• None other than standard regulatory and travel requirements as applicable per role location