Associate Director Regulatory Affairs

11 hours ago

Woburn, Massachusetts, United States Replimune, Inc. Full time
Job Summary

We are seeking an experienced Associate Director, Regulatory Affairs to join our team at Replimune, Inc. in Woburn, MA. The successful candidate will be responsible for executing clinical and preclinical regulatory strategies and activities, including timely preparation, review, and submission of clinical and preclinical documents to regulatory authorities.

Key Responsibilities
  • Develop and implement the overall clinical and nonclinical global regulatory strategy across the product lifecycle towards initial approval, launch, and label expansions.
  • Collaborate with regulatory and cross-functional teams to develop and manage specific product development plans.
  • Provide regulatory input and guidance to clinical and nonclinical development plans.
  • Ensure consistent application of the clinical regulatory strategy through consultation and review of clinical study protocols, statistical analysis plans, and study reports.
  • Identify and implement regulatory initiatives to facilitate and expedite patient access to the product.
  • Coordinate and ensure timely preparation, review, and submission of clinical and nonclinical documentation packages for regulatory agency interactions.
  • Develop the strategy and plan for an accepted investigation in pediatric patients in compliance with EMA, UK, and FDA.
  • Develop submission plans and timelines for clinical and nonclinical sections in partnership with CMC Regulatory.
  • Triage, coordinate, and manage responses to questions from regulatory authorities.
  • Influence strategy to address internal or external business and regulatory issues.
  • Identify, assess, and communicate potential risks associated with development and regulatory strategy scenarios.
  • Partner with commercial team and labeling specialist to develop and maintain the target product profile and target product label.
  • Monitor agency meetings, workshops, and publications to maintain company awareness of evolving regulatory landscape.
  • Perform ad hoc research on specific regulatory topics to support product development.
Requirements
  • BA or BS degree, MS preferred, in an appropriate scientific field with 10+ years' experience in Pharmaceutical/Biotech Industry with 5+ years in a Clinical Regulatory Affairs capacity.
  • Professional knowledge and skills working with solid tumor oncology therapeutics is required with biologic, gene therapy, or vaccine experience preferred.
  • Team player with confidence, coupled with excellent written and verbal communication skills as well as outstanding analytical abilities.
  • Previous experience in representing the sponsor in front of regulatory agencies and as primary regulatory author for regulatory submission documents.
  • Expedited approval pathway, rare disease, and commercial experience preferred.
  • Highly knowledgeable in ICH, FDA, and EMA regulations and guidelines and experience working in a global environment.
  • Skilled in multiple computer-based tools, in addition to software programs such as MS Office.
  • Strong interpersonal, organizational, and time management skills with attention to detail.
  • Ability to problem-solve and maintain composure in difficult situations.
  • Ability to work independently and manage multiple projects in a fast-paced environment.
  • Capable of handling matters of strict confidentiality and sensitivity.
  • Appropriate GCP or GXP training.
  • Experience with the development and support of related SOPs and policies is expected.
  • Ability to relate and work with a wide range of people to achieve results.
  • Successful and superior influencing skills across all levels of the organization and with external collaborators.
  • Problem-solving and risk-mitigation skills.
  • Ability to build working relations throughout the organization and with business partners to achieve business goals.
  • Ability to travel approximately 10% of time.
Location

This position is based in our Woburn office and welcomes hybrid work. Local candidates are expected to be on-site 2 days per week.

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