Require Regulatory Management Specialist at Merck Limited | M.Pharm, M.Sc
Merck Limited (formerly E. Merck Limited) was set up in India as the first Merck subsidiary in Asia in 1967. The Company operates both its Pharmaceuticals and Chemicals businesses in the country. Merck was also the first Merck Group Company to go public in the year 1981. The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd. and National Stock Exchange of India Ltd. Merck Specialities Pvt. Ltd., the wholly owned Indian subsidiary of Merck KGaA, was incorporated in 2005.
Post : Regulatory Management Specialist
• Effective networking with the key Government Authorities for priority topics such as Aseptic processing, Process Materials, Dual used Products, API’s, Excipients, Rapid sterility, MD/IVDs, ABP regulations etc
• Determine the correct classification and the most effective regulatory pathways for the selling of healthcare and diagnostic products, research, active pharmaceutical ingredients, excipients, new dietary ingredients and food additives as applicable into specified regional market specifically in Indian Market.
• Oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions.
• Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of business interests.
• To arrange governance meeting and track the actions status to bridge the gaps as per regulatory requirements.
• To review WHO- GMP, GLP and Schedule M checklist and to verify the compliance as per the checklist.
• Prepare, review and updating of Presentations, follow-up and getting approval in timely manner and ensure it meets the current regulatory requirements.
• Regularly monitoring CDSCO, FDA websites and gazettes notifications
• Preparation and submission of application, follow-up and getting approval for following:
• Registrations, Import permits, Additional product permission from, CDSCO & related Indian Authorities
• WHO-GMP, GLP, Test licenses, Tender certificates, PTL related approvals
• Conducting Regulatory awareness and training for all internal and external customers
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Develop and maintain standard operating procedures or local working practices
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
• Develop regulatory strategies and implementation plans for the preparation and submission of new products
• Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
• Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
• Contribute to the development or implementation of business unit strategic and operating plans
• Master of Pharmacy/ Master / Ph.D. in life sciences or related science. Bachelor/Masters degree in life science related discipline.
• Fluent in English & Hindi (verbal and written) is required.
• Minimum of 5-9 years of relevant industry experience and/or regulatory management related to biopharmaceutical products, pharmaceutical substances, process materials & life science.
• Knowledgeable of drug regulations and regulatory landscape of other important country/regions (eg. US & European Countries) including India
• Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, aseptic processing and validation procedures.
• Experience working in a global, matrix environment.
• Good presentation skill.
• Strong organizational and time management skills.
• Good project management skills.
• Ability to train and educate others.
• Effective management by influence.
• Effective people management.
• Some experience in thought leadership.
• Ability to work in multi-cultural teams.
• Good listening skills with the ability to analyze and respond to given situations quickly and effectively.
• Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.
• Ability to indirectly influence other organizations and cultures.
• Proficient in MS Office Software (Word, Excel, PowerPoint, Project).
Experience : 5-9 years
Location : Mumbai
Qualification : Professional
Industry Type : Pharma/ Healthcare/ Clinical research
Job Requisition ID : 195885
End Date : 20th September, 2019
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