Anandharaj A.
Assistant General Manager-Regulatory Affairs at Axxelent Pharma Science Pvt. Ltd.
- Role
- Assistant General Manager at Axxelent Pharma Science Pvt Ltd
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
Experience
Assistant General Manager
Axxelent Pharma Science Pvt Ltd
Jan 2021 — Present · Tamil Nadu, IN
Design/develop a regulatory strategy for new generic/hybrid applications for global markets.· Ensure that regulatory submissions are complete/prepared following the current standards in a timely manner, as well as that responses to requests from regulatory authorities are complete and timely prepared following the current standards.· Closely collaborate with affiliates and regional functions in handling requests and challenges related to regulatory aspects. · Be responsible for change management activities related to commercialised products and to establish clear process and SOPs for post-market regulatory activities.· Manage regulatory consultants.· Provide input into global strategy involving clinical and commercial objectives.· Plan and implement lifecycle management regulatory activities (e.g Annual reports, label and CMC changes).· Act as the primary contact with Regulatory Agencies.· Monitor changes in regulatory requirements and emergence of new regulations.· Prepare meeting requests, & briefing documents.· Coordinate and prepare teams for meetings.· Provide routine status updates to management.· Risk assessment and mitigation of regulatory compliance. · Experienced in the interpretation of regulations, guidelines, and policy statements.· Participate and represent Regulatory in meetings and interact with members of all development project teams to convey regulatory requirements · Interact with USFDA regulatory agent as required in a timely and appropriate manner to respond to any questions during the review process.· Guide internal employees on creation of regulatory documents.· Ensure the maintenance of regulatory database and departmental filing systems to facilitate accurate and retrievable records of regulatory activities.· Development of best practices for Regulatory Affairs processes.
Education
Anna University of Technology, Tiruchirappalli
M.Pharmacy
2006 — 2008
R.V.S. COLLEGE OF PHARMACEUTICAL SCIENCES (Inst. Code - 079), COIMBATORE
B.Pharmacy
2002 — 2006
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