Associate Manager Regulatory at Merck Limited

Post : Associate Manager Regulatory
Job Description
• 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 updation of PPIs, 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
• Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations

Candidate Profile
Education and Languages:
• Master of Pharmacy/ Master / Ph.D. in life sciences or related science with a strong emphasis in biologics.
• Fluent in English & Hindi (verbal and written) is required.

Professional Skills and Experiences:
• Minimum of 10 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.
• Knowledge of regulations for Advanced Therapeutic Medicinal Products (cell, gene therapy).
• Knowledge/experience for regulations concerning complex biologics (i.e., monoclonal antibodies and recombinant proteins) expressed in mammalian cell culture.
• Experience working in a global, matrix environment

Personal Skills and Competencies:
• Good presentation skill.
• Strong organizational and time management skills.
• Good project management skills.
• Ability to train and educate others.
• Effective management by influence.
• 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).
• Able and willing to travel frequently

Additional Information
Experience : 10 years
Qualification :  Ph.D, M.Pharm, M.Sc
Location : Delhi or Mumbai
Industry Type : Pharma
Functional Area : Regulatory
Job Requisition ID:  179416
End Date : 25th August, 2018