Senior Manager

Roles and Responsibilities :

• Manage regulatory affairs for solid oral dosage forms, ensuring compliance with USFDA regulations.
• Develop and implement effective strategies to maintain regulatory approvals and ensure timely product launches.
• Collaborate with cross-functional teams to resolve regulatory issues and provide guidance on product development.
• Provide expert advice on regulatory requirements to internal stakeholders, including marketing, manufacturing, and quality control.

Job Requirements :

• 12-20 years of experience in pharmaceutical industry with a focus on solid orals and regulatory affairs.
• Strong understanding of USFDA regulations and guidelines governing drug products.
• Proven track record of successfully managing complex regulatory projects from concept to execution.