Strategic Regulatory Affairs Manager, Oncology

BioSpace; Warren; On-site; GBP 95,000 - 154,000; Full time

Job summary

Regeneron is seeking a Manager to join the Regulatory Affairs Strategy Oncology team.

The 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.

Qualifications

• Minimum MD, PhD or PharmD degree with 2+ years of regulatory experience.
• Experience filing, developing regulatory documents, interacting with external partners/authorities.
• Understanding of US FDA and international pharmaceutical guidance and regulatory practices.
• Experience interacting with CROs for ex-US/ex-EU CTAs preferred

Responsibilities

• Coordinate preparation, submission, management and maintenance of global regulatory submissions (INDs/CTAs, amendments, information requests, Orphan drug applications, Annual Reports, Investigators Brochure).
• Assist in Agency meeting coordination and briefing document preparation.
• Lead and track queries with regulatory agencies and provide written responses with SMEs.
• Represent study-level regulatory activities and participate in cross-functional teams.

Skills

Regulatory submissions

Cross-functional collaboration

US FDA knowledge

Attention to detail

Project coordination

Written/verbal communication

Education

MD/PhD/PharmD degree

Job description

Regeneron is seeking a Manager to join the Regulatory Affairs Strategy Oncology team.

The 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.