Bachelor's degree in life sciences or related field is required., Minimum of 5 years of experience in regulatory affairs, preferably in the pharmaceutical industry., Strong knowledge of FDA regulations and submission processes is essential., Excellent communication and analytical skills are necessary for this role..
Key responsibilities:
Prepare and submit regulatory documents to health authorities.
Collaborate with cross-functional teams to ensure compliance with regulations.
Monitor and interpret regulatory changes and their impact on the organization.
Provide guidance on regulatory strategy and risk assessment for product development.
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