ResponsibilitiesMaintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports. Independently and proactively request documentation required for annual reports, compile, finalize and publish for managements review and subsequent dispatch to the Agency Independently work on supplements, compile and publish for managements review. Take a proactive approach for more complex submissions and contact internal stakeholders (when needed) to gain further insight on any given supplement. Convey findings to management and incorporate any.all applicable information in the submission to ensure a quality and a right first time submission. Assist management and proactively train Associate I’s and Associate II’s on guidance’s, internal processes, procedures, databases and trackers Other projects and duties as required/assigned. Process improvementQualification & ExperienceM. Pharma degree in RA/QA discipline, a plus. Minimum 5+ years pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory or production experience preferred. Demonstrates an understanding of ICH and FDA guidelines Demonstrates the ability to evaluate regulatory documents and determine appropriate action.

Responsibilities Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.  To review specification for bulk drug and formulations as per regulatory expectation.  Responsible for reviewing clinical trial and bioequivalence study documents to be submitted in regulatory applications.  To search literature through various websites as per the application strategy.  To prepare rationale on safety and efficacy of new drug/FDC by referring published literature.  To prepare executive summary for SEC referral for drugs not approved in India.  To get all final CMC/CT/BE final documents from cross functional team and compilation of dossier for regulatory submission.  To file ND/SND/FDC application on SUGAM portal for getting domestic manufacturing and marketing permission / clinical trial permission etc.  To review draft specimen or label and carton.  To prepare prescribing information by referring international prescribing information .Qualification & ExperienceM. Pharm Experience Tenure : 2 – 4 Yrs.

Responsibilities  Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.  API DMF and DMF Change Notification review with respect to USFDA regulatory requirement.  Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects.  Ability to preliminary review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling  Drafting of the Annual Report with required submission data as per USFDA guidance.  Preliminary review of entire submission package.  Drafting the controlled correspondence/Briefing Package to FDA on specific cases as needed for assigned projects.  Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames.  Coordination with Cross Functional teams for the documents availability as per regulatory submission plan.  Ensure the no delay in drafting and compiling the regulatory submission.  Maintain regulatory information as per allocated task. Qualification & ExperienceB. Pharm B. Pharm - Required M. Pharm M. Pharm - Preferred Experience: 5 years or more in 5 - 8 Years

ResponsibilitiesResponsible for Medical Device and Drug registration in CDSCO, State FDA office and other government office. Liaising with key health authority agencies during development, registration, and product lifecycle activities to resolve regulatory issues and/or negotiate approvals. Execution of Regulatory Submission plan. Manage Regulatory Information Management System (RIMS) to ensure all product information for medical devices and drugs is contemporaneous, accurate, and compliant to support uninterrupted market supply. Maintain up-to-date local registration dossiers, technical files, regulatory resources, and applicable legislation for both drugs and medical devices for India market. Provide regular updates in the Global Regulatory Roadmap and RIMS on the registration status of all products, including updates to the local country Roadmap. Implementation of Quality Management System (QMS) as part of a broader regional quality initiative. Ensure all labelling/ redressing activities are conducted in full compliance with Good Manufacturing Practice (GMP) requirements. Responsible for MRP implementation and NPPA compliance.Qualification & Experience Education and qualifications required or expected Degree in Pharmacy, Chemical, Bioengineering, Health Professional. Desirable master’s degree in quality, regulatory, science or pharmacy  Professional Experience (in years): At least 5 years of Industrial experience in Medical Device or healthcare Industry and strong engagement HAs.

Responsibilites Domestic regulatory filing and approval. Submission of registration dossier/s as per MOH requirements initially in countries, to explore further in different markets as per managements decision. Review/Gap analysis of the existing versus US/EU regulations & dossiers as per ICH guidelines, country specific requirements. Maintain current knowledge of relevant regulations for registrations in International markets. Coordinate with regulatory activities such as international audits & regulatory agency inspections, product recalls. Planning dossier submission timelines in coordination with QA. Qualification & ExperienceM.Pharm ( RA / QA ) Relevant Skills / Industry Experience 10-15 Years in Regulatory/ Compliance Related Activities

ResponsibilitiesProvide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals. Develop the international regulatory strategy and contribute to Global regulatory plans. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments). Support and advise on the local label strategy and alignment to cCDS/reference label. Build effective relationships and communication paths across global, regional, local and functional organizations. Enable efficiencies and seamless execution across the international countries. Contribute to process improvement projects, as assigned.Qualification & ExperienceDoctorate degree and 6 years of directly related experience OR Master’s degree and 8 years of directly related experience OR Bachelor’s degree and 10 years of directly related experience