Regulatory Affairs Manager

• Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.

• Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.

• Develop regulatory submission strategies in agreement with defined product development objectives.

• Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications (NDA) projects. Prepare and submit IND and NDA applications, as well as various amendments and supplements.

• Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.

• Prior management experience, with a demonstrated capability to lead and motivate staff is essential.

• Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical.

Qualifications

• Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
• Prepare and submit IND and NDA applications, as well as various amendments and supplements.
  

Additional Information

Thanks and regards,

Sneha Shrivastava

862 579 4236