Katalyst CRO · 6 days ago
Regulatory Affairs Senior Manager
Madison, NJ
Contract
Onsite
Mid, Senior Level
4+ years expKatalyst CRO is seeking a Regulatory Affairs Senior Manager to oversee communication with the FDA and manage regulatory processes for pharmaceutical products. The role involves leading a team in the preparation and filing of regulatory submissions, ensuring compliance with FDA guidelines, and providing regulatory guidance across departments.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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 FDA's 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 guidance's 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
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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