RegulatoryÂ AffairsÂ SeniorÂ Manager

Tarrytown, NY - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Responsibilities:

US Agent for all products responsible for communication between the FDA and manufacturing sites.
Communicate and follow-up status with FDA for any Chemistry Bioequivalence and Patents issues and correspondences on both pending and approved applications.
Lead guide and train the CMC team to ensure highly qualified personnel that can perform to meet company KPO Preparation Review and filings of new ANDA NDA IND and DMF for the U.S. FDA in eCTD format.
Preparation Review and filing of all post marketing activities which include timely submission of Annual Reports CPP release of detained products at customs etc.
Respond to deficiencies related to Chemistry Bioequivalence and Patent in a timely manner.
Review and approve Prototype formulation during early drug development stages to be compliant with Inactive Ingredient Database and FDA guideline.
Review and submit Controlled Correspondences related to product under development.
Preparation submission and monitoring of PLAIR activities prior to new product launch.
Manage regulatory correspondence mainly to CDER FDA User fee staff drug listing and Board of Pharmacies for state licensing submissions.
Provide regulatory guidance to R&D Technical Operations Sales and Marketing Quality Clinical Legal.
Contact FDA and participate in Pre-IND and Pre-NDA meetings. Prepare review and file the package for these meetings.
Communicate and follow-up with FDA for any issues responses status for pending and approved applications.
Respond to FDAs request expeditiously.
Review and provide guidance for Citizen Petitions. Prepare review and file suitability petitions and control correspondence.
Monitor FDA websites for new and/or updated guidances and implement and guide the team as required.
Review and approve all change controls from manufacturing sites when required.
Provide guidance and advise management regarding improvement in CMC harmonization process of regulatory documentation at all manufacturing sites.
Active participation in Lesson learned process derived from regulatory correspondences.
Support TA Labeling team when required.
Participate in decision making process with other applicable departments.
Prepare and evaluate the performance of the individuals in the department.
Coordinate with global and local affiliates.

Requirements:

MS in Life Sciences.
4-5 years of proven experience in working with the FDA and managing regulatory team in the generic pharmaceutical industry.
Strong background in CMC aspects of drug product registration knowledge of U.S. drug registration (NDA ANDA DMF & INDs) and with U.S. drug product labeling requirements.
Excellent verbal/written communication skills computer skills and attention to detail.
Excellent teamwork abilities.

Responsibilities: US Agent for all products responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for any Chemistry Bioequivalence and Patents issues and correspondences on both pending and approved applications. Lead guide and train the CM...

Responsibilities:

US Agent for all products responsible for communication between the FDA and manufacturing sites.
Communicate and follow-up status with FDA for any Chemistry Bioequivalence and Patents issues and correspondences on both pending and approved applications.
Lead guide and train the CMC team to ensure highly qualified personnel that can perform to meet company KPO Preparation Review and filings of new ANDA NDA IND and DMF for the U.S. FDA in eCTD format.
Preparation Review and filing of all post marketing activities which include timely submission of Annual Reports CPP release of detained products at customs etc.
Respond to deficiencies related to Chemistry Bioequivalence and Patent in a timely manner.
Review and approve Prototype formulation during early drug development stages to be compliant with Inactive Ingredient Database and FDA guideline.
Review and submit Controlled Correspondences related to product under development.
Preparation submission and monitoring of PLAIR activities prior to new product launch.
Manage regulatory correspondence mainly to CDER FDA User fee staff drug listing and Board of Pharmacies for state licensing submissions.
Provide regulatory guidance to R&D Technical Operations Sales and Marketing Quality Clinical Legal.
Contact FDA and participate in Pre-IND and Pre-NDA meetings. Prepare review and file the package for these meetings.
Communicate and follow-up with FDA for any issues responses status for pending and approved applications.
Respond to FDAs request expeditiously.
Review and provide guidance for Citizen Petitions. Prepare review and file suitability petitions and control correspondence.
Monitor FDA websites for new and/or updated guidances and implement and guide the team as required.
Review and approve all change controls from manufacturing sites when required.
Provide guidance and advise management regarding improvement in CMC harmonization process of regulatory documentation at all manufacturing sites.
Active participation in Lesson learned process derived from regulatory correspondences.
Support TA Labeling team when required.
Participate in decision making process with other applicable departments.
Prepare and evaluate the performance of the individuals in the department.
Coordinate with global and local affiliates.

Requirements:

MS in Life Sciences.
4-5 years of proven experience in working with the FDA and managing regulatory team in the generic pharmaceutical industry.
Strong background in CMC aspects of drug product registration knowledge of U.S. drug registration (NDA ANDA DMF & INDs) and with U.S. drug product labeling requirements.
Excellent verbal/written communication skills computer skills and attention to detail.
Excellent teamwork abilities.