Sr. RA Specialist
Core
Manage preparation of regulatory submissions to obtain approvals and provide regulatory input on matters for company products.
Role type
Senior Regulatory Affairs Specialist (Pharma)
Builds
Regulatory submissions and strategies for new assets and line extensions
Domain
Pharmaceutical industry, Oncology, Orphan Drug
Deliverable
client delivery
Required skills
Regulatory strategy development, cross-functional collaboration, regulatory research, compliance review of labeling/packaging, contract review, risk management, product discontinuation/withdrawal strategy, marketing authorization transfer strategy
Preferred skills
Oncology or Orphan Drug Designation experience, English proficiency (spoken and written), analytical and critical thinking, process improvement
Technologies
None stated
Responsibilities
Develop regulatory strategies for new assets and line extensions; Identify and resolve regulatory issues during product development, registration, or post-market phases; Collaborate with R&D, Quality Assurance, and Marketing to support regulatory activities; Review product labeling, packaging, and promotional materials for compliance; Conduct research on regulatory requirements and guidelines; Evaluate impact and implementation plans for marketed products; Manage variations in accordance with strategy; Review contract terms for regulatory implications
Seniority
Senior, hands-on IC
