Experienced Regulatory Affairs Professional supporting NCMR product development and registrations in EMEA at Johnson & Johnson. Collaborating on regulatory strategies and submissions while ensuring compliance.
Responsibilities
Support the EMEA Regulatory Liaison in developing the regulatory strategy for products
Assist in submissions to health authorities from early development, CTAs to MAAs and life-cycle management
Develop an understanding of regional regulatory environment and therapeutic areas
Act as backup for contact with EMA and national Regulatory Agencies
Collaborate with LOCs and track/respond to queries
Assist in the creation and revision of processes related to regulatory submissions
Draft and review document content based on regulatory knowledge
Provide regulatory support throughout the life-cycle of a product
Guide and collaborate with cross-functional teams on required documents
Requirements
Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred, or equivalent by experience
Proven experience of 2+ years in regulatory affairs or other relevant functions
Experience working in cross-functional teams
Knowledge of the pharmaceutical regulatory environment, guidelines, and practice in EMEA, particularly the EU.
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