Key Accountabilities: - Plan, strategize and monitor regulatory filings leading to timely submissions and approvals of new product registrations and variation applications - Liaise with local regulatory authorities to deliver timely registration approvals. - Life cycle management of existing product portfolio while ensuring smooth supply of products - Manage labelling changes, safety updates, artwork development and artwork approval of packaging material components - Build effective working relationships with the country regulatory agency and follow-up closely on approvals of product registration and variations - Build up and maintain a powerful - regulatory intelligence network- including the support of the global web-based Regulatory Intelligence tool - Work with all appropriate local functions to develop and implement the best regulatory plans to support commercial goals and product launch excellence. - Represent the company in key trade associations and is responsible that CH demands and positions are well represented - In cooperation with Global and regional RA Coordination make sure that all required RA systems are in place and accessible where needed to insure the global alignment of RA execution (dossiers, reporting, etc.) - Develop annual regulatory budget for India filings/ variations/ registrations/ licenses and manages the Company resources responsibly - Review India's promotional material in relation to product campaign launches and ongoing product marketing activity. Establishes an optimised flow of information regarding regional products to ensure availability to other markets, quality of dossiers and regulatory requirements. - Update and maintain local and global-associated database of India's regulatory information - Maintain updated information on the latest pharmaceutical regulatory developments affecting India Strategic Impact: Deliver a regulatory strategy for India across all Consumer Health products categories in the region (OTC Pharmaceuticals, Rx Pharmaceuticals, 2 of 3 Phytomedicines, Medical Devices, Nutritional products such as Food/ Dietary Supplements, and others when applicable) to support business at its best. Deliver a local execution of all regulatory tasks: -&nbsp; Registration of new products according to business strategy -&nbsp; Maintaining the existing portfolio in line with business strategy in a cost effective way - Having all the Regulatory systems in place to guarantee a compliant and highest quality execution of all tasks - Represent the company at all relevant authorities for registration related activities and discussion with legislators, e.g. commenting legislative initiatives of authorities to achieve the best possible business environment. - Represent the company with the country RA organisation in key industry trade associations to ensure an effective environment to develop the business model with - High innovation potential - Fast market access - Low/ reasonable costs for LCM in cooperation with the regional office Scope of People Responsibility: - Managing the local CH RA representatives either provided by Company or external, and consultants and outsourced resources acting on behalf of Company CH products and business, where applicable Education: - Minimum of a Degree in Science or Pharmacy - Good knowledge of current regulatory requirements - Professional experience as a combination of Regulatory / Medical responsibilities would be a significant advantage Work Experience -&nbsp; - Minimum of 10 years of Regulatory Affairs experience in the pharmaceutical, consumer healthcare, nutrition or OTC industries. Job specific Competencies &amp; Skills: - Professional written and verbal communication skills - Team work and people management skills - Good time management skills, with ability to multi-task

Mumbai

Merck Group - Head - Regulatory Affairs - Consumer Health Segment 

Merck Group - Head - Regulatory Affairs - Consumer Health Segment  ,Job Description for Merck Group - Head - Regulatory Affairs - Consumer Health Segment  in Merck Group in  Mumbai for (10-15) years of experience. Apply Now!

Job Description for Merck Group - Head - Regulatory Affairs - Consumer Health Segment  in Merck Group in  Mumbai for (10-15) years of experience. Apply Now!