Job Description

Join to apply for the Regulatory Affairs Manager role at Katalyst CRO

11 months ago Be among the first 25 applicants

Join to apply for the Regulatory Affairs Manager role at Katalyst CRO

Get AI-powered advice on this job and more exclusive features.

• Regulatory submissions including Original ANDAs, Amendments, Annual Reports, Supplements and PADERs to company applications.
• Preparation/Review of Original submission/Amendments/ Supplements as assigned by the Director, Regulatory Affairs or VP, Regulatory Affairs.
• Participate in project calls with minimal supervision and work very closely with internal and external project managers, contract manufacturers to ensure timely availability of documents for submission.
• Review the submission documents for accuracy and adequacy and approach the management immediately for any questions or concerns.
• Stay updated on the Agency's expectations based on guidance's/ deficiencies and apply the same logic for future submissions to avoid any similar deficiencies.
• Ensure the facilities used in company's applications commit to GDUFA requirements (site identification, facility fees).

• Regulatory submissions including Original ANDAs, Amendments, Annual Reports, Supplements and PADERs to company applications.
• Preparation/Review of Original submission/Amendments/ Supplements as assigned by the Director, Regulatory Affairs or VP, Regulatory Affairs.
• Participate in project calls with minimal supervision and work very closely with internal and external project managers, contract manufacturers to ensure timely availability of documents for submission.
• Review the submission documents for accuracy and adequacy and approach the management immediately for any questions or concerns.
• Stay updated on the Agency's expectations based on guidance's/ deficiencies and apply the same logic for future submissions to avoid any similar deficiencies.
• Ensure the facilities used in company's applications commit to GDUFA requirements (site identification, facility fees).

• Degree in Science with at least 10 years of experience in the pharmaceutical industry.
• Understanding of regulations relating to generic pharmaceuticals.
• Understanding of generic drug approval process and associate regulations.
• Capable of technical review of documents submitted in applications.
• Organizational skills and multi-tasking.
• Excellent written and verbal communication skills.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Legal

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Katalyst CRO by 2x

Get notified about new Regulatory Affairs Manager jobs in San Jose, CA .

Senior Regulatory Affairs Specialist - Vascular (on-site)

Sr Regulatory Affairs Specialist (Remote) - Shockwave

Santa Clara, CA $89,000.00-$165,600.00 4 days ago

Sunnyvale, CA $80,000.00-$140,000.00 7 months ago

Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave

Santa Clara, CA $89,000.00-$165,600.00 3 days ago

Senior Manager, Renewables Regulatory NERC & Operational Compliance

Redwood City, CA $190,000.00-$220,000.00 2 weeks ago

Sr Regulatory Affairs Specialist - Shockwave Medical

Santa Clara, CA $89,000.00-$165,600.00 3 days ago

Senior Regulatory Affairs Specialist -Vascular (on-site)

Regulatory Affairs Manager Heart Failure (on-site)

Pleasanton, CA $112,000.00-$224,000.00 2 weeks ago

Senior Regulatory Affairs Specialist Vascular (on-site)

Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)

Regulatory Affairs Manager Vascular (on-site)

Johnson & Johnson, Sr Regulatory Affairs Specialist (Remote) - Shockwave - Application via WayUp

Santa Clara, CA $89,000.00-$165,600.00 2 days ago

Sr Regulatory Affairs Manager, Abbott Ventures - Transcatheter Mitral Valve Replacement (on-site)

San Jose, CA $171,733.00-$257,599.00 2 days ago

San Jose, CA $171,733.00-$257,599.00 2 days ago

Senior Regulatory Affairs Specialist - Investigational Device Exemption (IDE)

Sunnyvale, CA $119,900.00-$203,000.00 2 weeks ago

San Jose, CA $171,733.00-$257,599.00 2 days ago

Sr. Manager, Payor Relations and Regulatory Compliance

Lead Product Manager - Regulatory Compliance

Sr. Manager, Payor Relations & Regulatory Affairs

Regulatory Compliance Manager (Wireless Devices)

Morgan Hill, CA $175,000.00-$225,000.00 5 days ago

Sunnyvale, CA $135,500.00-$229,500.00 2 weeks ago

San Jose, CA $102,400.00-$204,100.00 4 days ago

Vice President, Legal Affairs (Litigation, Regulatory & Public Policy)

Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery, Inc.

San Jose, CA $150,000.00-$180,000.00 1 week ago

Manager, HW Regulatory Compliance Engineering

Sunnyvale, CA $135,900.00-$234,900.00 1 week ago

Santa Clara, CA $86,700.00-$173,300.00 5 days ago

Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Job Tags

Similar Jobs