Regulatory Compliance Lead managing documentation and compliance operations across North America and LATAM. Leading a team to ensure regulatory standards and documentation accuracy.
About the role
- 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.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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