Head of Regulatory Affairs
This role leads the Regulatory Affairs unit of EMD Millipore Corporation in North America having responsibility for product registration and Hazard Communication in Chemicals.
Responsibilities:
· Set up regulatory strategies for EMD Millipore products in North America
· Design and implement workflows and procedures based on governance from EQ-R and MM-Q Regulatory Compliance Strategy. Owns regulatory decisions for North America.
· RA knowledge for North America and extensive product knowledge for Merck Chemicals portfolio
· Interface with Business Units as the RA point of contact
· Identify changing requirements due to external regulations and internal marketing strategies and plan and carryout respective registration/notification/listing activities in North America
· Provide RA guidance in risk assessments and for decision-making in product crisis situations
· Ensures the FDA site registration including Drug (CDER), Medical Devices (CDRH) and Food Facility (NDC)
· Act as US agent for Merck Darmstadt and subsidiaries BBMF fillings
EXPERIENCE REQUIRED:
- BS in Chemistry, Biology or related health science
- Minimum of 10 to 15 years of Regulatory Affairs experience
EXPERIENCE PREFERRED:
- MS in Chemistry
- Multilingual SAP computer software knowledge experience
- FDA Electronic Registration Experience
Additional Information:
- Travel Percentage: 15%
