Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Post : Head Regulatory Affairs - DCV & Established Products
Job Description
• Accountable to MCO/Country Business Unit Regulatory Head for the management of Regulatory Associates team in charge of development/maintenance projects,
• Responsible for managing the regulatory strategy, the preparation and on-time delivery of compliant major submissions to Regulatory Agencies and for managing responses to Regulatory Agencies questions,
• Responsible to know, to adhere to and to advise others on Regulatory Authority regulations and guidance,
• Ensure compliance of all regulatory activities with all applicable laws, regulations, Regulatory Authorities requirements and company procedures,
• Provide guidance to various teams and stakeholders across the company organization on regulatory requirements/policies for development and marketed products,
• Lead and manage the submission teams and responses team throughout the regulatory processes,
• Participate in discussions/meetings with Regulatory Authorities as required,
• Participate in other projects and activities, such as leading implementation of changes to processes,
• Accountable for keeping the databases updated on a timely basis for portfolio he/she is in charge of.
• Provide support and communicating information on products to other functions ( submissions, approvals, ...).
• Liaise with HA contact person; organizing and preparing HA meeting and leading.
• Manage activities such as shortages, DHPC, B/R reevaluation, etc.
• Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
• Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies
• Work in compliance with Sanofi Quality Documents (QDs),
• Train/coach Regulatory Associates in his/her team
• Develop good relationship with third parties, providing regulatory guidance and leadership for in/out license compounds (if applicable).
• Accountable to MCO/Country Business Unit Regulatory Head for the management of Regulatory Associates team in charge of development/maintenance projects,
• Responsible for managing the regulatory strategy, the preparation and on-time delivery of compliant major submissions to Regulatory Agencies and for managing responses to Regulatory Agencies questions,
• Responsible to know, to adhere to and to advise others on Regulatory Authority regulations and guidance,
• Ensure compliance of all regulatory activities with all applicable laws, regulations, Regulatory Authorities requirements and company procedures,
• Provide guidance to various teams and stakeholders across the company organization on regulatory requirements/policies for development and marketed products,
• Lead and manage the submission teams and responses team throughout the regulatory processes,
• Participate in discussions/meetings with Regulatory Authorities as required,
• Participate in other projects and activities, such as leading implementation of changes to processes,
• Accountable for keeping the databases updated on a timely basis for portfolio he/she is in charge of.
• Provide support and communicating information on products to other functions ( submissions, approvals, ...).
• Liaise with HA contact person; organizing and preparing HA meeting and leading.
• Manage activities such as shortages, DHPC, B/R reevaluation, etc.
• Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
• Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies
• Work in compliance with Sanofi Quality Documents (QDs),
• Train/coach Regulatory Associates in his/her team
• Develop good relationship with third parties, providing regulatory guidance and leadership for in/out license compounds (if applicable).
Candidate Profile
• Physician, Pharmacist, Veterinarian or preferably Life Sciences Master Degree
• Related Experience : Minimum of 10 years experiences in Pharmaceutical development, Regulatory Affairs, Clinical, Pharmacovigilance or Quality Assurance
• Project management experience in the pharmaceutical industry or in a regulatory environment. Recognized expert in managing matrix teams.
• Physician, Pharmacist, Veterinarian or preferably Life Sciences Master Degree
• Related Experience : Minimum of 10 years experiences in Pharmaceutical development, Regulatory Affairs, Clinical, Pharmacovigilance or Quality Assurance
• Project management experience in the pharmaceutical industry or in a regulatory environment. Recognized expert in managing matrix teams.
Additional Information
Experience : 10 years
Qualification : Pharmacist, Veterinarian or preferably Life Sciences Master Degree
Location : Mumbai
Industry Type : Pharma
Functional Area : DCV & Established Products
End Date : 20th December, 2018
Experience : 10 years
Qualification : Pharmacist, Veterinarian or preferably Life Sciences Master Degree
Location : Mumbai
Industry Type : Pharma
Functional Area : DCV & Established Products
End Date : 20th December, 2018
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