?Liaise with Country Head of RA, RA HQ, regional RA AP team and other stakeholders to:
Develop registration strategy and milestone plan for new drugs in line with local business priorities and export business.
Manage the compilation and submission of applications for product registration and maintenance of licenses.
Provide regulatory input in order to obtain timely regulatory approvals for the products by coordinating with other relevant functions.
Support the regulatory activities for imported products and overseeing product registration for Exports.
Work closely with local TechOps organization to ensure regulatory compliance of locally manufactured products, to ensure required licenses for proper product distribution are in place, including artwork maintenance, regulatory input into issue management.
Responsible for managing Manufacturing License applications/renewals, Artwork preparations & management, support to tender business by procuring relevant certificates.
Responsible for Regulatory compliance, including:
Prepare RA report and ensure global and local registration database are updated timely and in accordance with applicable local/global guidance documents.
Provide RA division support to plan and prepare for inspection by health authorities and internal audits.
Support internal partners by giving regulatory input / recommendation to ensure that company comply with current applicable regulatory affairs laws and regulations.
Regulatory quality management: Responsible for local and internal compliance to regulatory affairs relevant processes and systems.
Ensure regulatory compliance for a sustainable life-cycle management: Labeling, CMC changes and MA Lifecycle support are performed in
accordance with local regulations and relevant SOPs.
Ensure mandatory compendial /Pharmacopoeia compliance of input materials and finished products. Obtain revised product permission from State Drug Authorities in case of compendial / Pharmacopoeial amendments of finished product label claim.
Work closely with RA India team to prepare application files for products based on the documentation provided from local/regional/global RA and other cross-functional partners in accordance with local regulations, of acceptable standard and quality to present them to the Health Authority.
Handling the test license applications to the zonal offices for import of required materials for testing in India. Co-ordinate testing of drug formulations at central drug testing laboratory and other laboratories as relevant as part of the registration process as well as commercial consignments. Provide technical support for the analysis of imported products by Authorities or the samples drawn by ADC customs.
Provide updated regulatory intelligence by identifying current and emerging national regulations (requirements, guidelines) which impact the drug development and / or marketing processes and ensures appropriate contribution and communication with all involved functions (BU, Medical team, RA-AP etc.) in order to ensure regulatory compliance and support marketing plan. Estimation and evaluation of regulatory intelligence and requirements to take appropriate actions and cascade the relevant BU's. Contributes actively to design and assessment of RA strategic options.
?A pharma MNC
?Post graduate (preferably Pharmacy) with at least 5 years of regulatory experience.
The experience must include at least few years of operational experience in handling regulatory activities for locally manufactured products, imported products and export to neighboring countries.
Exposure of formulation and development and/or quality assurance activities is highly desired.
In depth understanding of CMC, non-clinical and clinical data aspects for regulatory submission.
Strong managerial and leadership skills to lead and motivate cross functional teams, in line with our company LIFE values.
Excellent computer skills in MS office particularly in MS Word, Power point, Excel etc.
Good communication, presentation and negotiation skills with positive and learning attitude.