Sr. Manager-Drug Regulatory Affairs

0 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Alder Biochem Private Limited

time outline icon Dehradun, Uttarakhand, India

Posted on 25-12-2024

53 Views

1 Vacancy

Description

Lead and manage the regulatory affairs team to ensure compliance with local, national, and international regulatory requirements for drug products.
Oversee the preparation, review, and submission of regulatory dossiers, including new drug applications, amendments, and renewals.
Liaise with regulatory agencies, providing expert guidance and ensuring timely approvals for drug products.
Monitor and interpret regulatory changes, ensuring company products are compliant with updated standards and regulations.
Develop and implement regulatory strategies for drug development, ensuring alignment with business goals and regulatory timelines.
Provide guidance on labeling, packaging, and advertising, ensuring compliance with regulatory guidelines.
Review and approve regulatory documents, including clinical trial applications and marketing authorizations.
Collaborate with R&D, quality control, and manufacturing teams to ensure regulatory compliance during product development and manufacturing processes.
Ensure that all regulatory documentation is accurately maintained, up-to-date, and easily accessible.