Support India Extended Hub Regulatory Affairs programs and activities for new product registration and life-cycle management of CP portfolio, including but not limited to, product registration renewals, variations, notifications and/or new license applications.

• Assist in the implementation of the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to India Extended Hub Regulatory Affairs Lead with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.

• Work closely with the Global Regulatory Operation team to compile documents and information required for high quality and successful submissions, license renewals and annual registrations, and maintenance of product registration dossiers for authorities.

• Assist in preparing submissions to Competent Authorities, for timely approval of new products and life-cycle submissions.

• Track outstanding documentation and notify the India Extended Hub Regulatory Affairs Lead in a timely manner.

• Inform India Extended Hub Regulatory Affairs Lead of upcoming renewals and commitments in a timely manner. 

• Assist in the electronic submission of product dossiers, variations and responses to Competent Authorities.

• Update and maintain product registration and ingredients archives, databases and tracking tools.

• Upload and maintain technical files/dossier databases for the products.

• Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.

• Ensure proper electronic archiving of all documents submitted to and received from Competent Authorities, as well as accurate and timely data update of regulatory compliance databases and tools for assigned products. 

• Assist with artwork review and approval as instructed by the direct manager.

• Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (cosmetics, medical devices, medicinal products, home care products, etc.)

• Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and agreements. 

• Track Competent Authority websites and databases for news related to regulatory developments.

• Assist India Extended Hub Regulatory team to deliver and manage RA assessments. 

• Assist India Extended Hub Regulatory team to deliver Regulatory training and contribute to the Regulatory training plan and modules.

• Collaborate closely with the Regulatory Operations team to ensure timely and accurate execution of assigned tasks.

• Ensure participation in key meetings for the regulatory function and provide timely feedback.

• Minimum, Bachelor’s degree in Pharmacy or Life Sciences or relevant education.  

• At least 3 years of relevant experience in regulatory affairs, quality or product development in pharmaceutical, medical devices or similar FMCG/CPG companies.

• Understanding of/exposure to the registration and regulatory requirements in India. Knowledge of the requirements of other countries in the hub will be an added advantage. 

• Knowledge of industry practices, techniques and standards.

• Knowledge and experience with medicinal products and medical devices is an advantage.

• Excellent computer skills, which includes working with electronic databases, eCTD software, MS Office applications (working with templates, and editing and formatting complex documents), Adobe Acrobat Standard or Professional, Internet and Intranet, Google Suite, SAP, DMS, and Authority Regulatory databases and portals for managing changes and submissions.