Job Description
Managing India OSD Pre-approval ANDA portfolio, Injectable Drug Substance pre-approval portfolio, Global DMF Review portfolio including global Nitrosamine risk assessment & DMF lifecycle.
Provide Drug substance/nitrosamine review support to complex projects, 505(b)(2), Europe & Canada projects.
Participating in cross-functional meetings for regulatory/technical issue handling as per the need
of project to facilitate appropriate decision making.
Participate in API vendor meetings to get the appropriate information from them to avoid any DS deficiencies.
Bridging the DMF/API related regulatory decisions between Raks & Amneal Teams.
Conducting training on regulatory topics at departmental and cross-functional level.
Performing final review of critical documents/submissions and ensuring quality of DMFs, Amendments etc.. for regulatory compliance.
Performing final review of critical documents/submissions and ensuring quality of ANDAs/S, Amendments etc.. for regulatory compliance.
Framing RA Strategy of ANDA/DMF/DS for ongoing projects to support R&D, Quality & other Depts.
Ensuring timely submissions to FDA, other regulatory authorities & customer requirements.
Leading Global DMF Team/Process & ensuring efficient review of DMFs (from Raks & Other API vendors) for all locations or Raks & Amneal for all dosage forms to comply with current FDA requirements, to support ANDA quality & first cycle approvals.
Coordinating between Raks, Amneal India & Amneal USA teams on global regulatory front for DMF/API.
Developing RA tools like internal checklists, databases etc.. as part of innovation & continuous improvement.
To coordinate with SSSM team/vendors for DMF/Excipient document requirement & issue handling.
To discuss & resolve DMF critical issues/open items/probable deficiencies with cross functional teams & to
escalate final open items to senior team, as required.
To support any regulatory information required for audits & when any RA advice/evaluation/clearance is needed.
To evaluate critical change notifications/CCFs & other documents to support launch activities, when required.
Manage to evaluate CCFs through team related to ANDA, Drug substance, vendor notifications & nitrosamine impact.
To take active part in implementation of new guidance requirements from USFDA.
Team handling and team development as per their specific roles.
Project distribution among groups/teams as per the workload and company goals.
Resource planning, Interview and selection of candidates, as needed.
Approving team’s attendance & other related matters.
Carry out yearly performance appraisal of the team members.
Signing cover letters, reports & other necessary documents, as needed for regulatory submissions to USFDA or for compliance
Qualifications
M. Pharm / M. Sc.
