Genpact Pharma Regulatory Affairs, pharmacy job opening 2023, Genpact announces job opening for pharma candidates. Regulatory affairs job opening 2023, Regulatory affairs recruitment 2023, Intrested and eligible candidates may check out all the details on the same below:
Job Title: Lead Consultant, Pharma Regulatory Affairs-LIF007033
Primary Location India-Mumbai
Eligbility Criteria:Â
B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
• Excellent Verbal and Written communication skills
• Ability to transfer knowledge
• Ability to engage with people immediately & build Relationship
• Team Management skills and proficiency
• Good client communication
• Basic project management skills
• Mentoring junior team members
Preferred Qualifications/skills
• Good at problem-solving & Decision Making
• Enthusiasm & confidence
• Adhere to our principles and values
• Time Management skills
• Organizational Skills
Responsibilities
- Dossiers preparation in CTD modules & submission
- Post-approval regulations
- Â Artwork updates- Liaising and coordinating with Labelling teams, supply and Quality. Proactive with Batch launching and delivery updates.
- Responsible for review and update of artwork if required
- Â Post-approval submission knowledge for EU markets
- Â Knowledge of manufacturing documents like batch records, specifications, analytical methods, validation reports, stability data.
- Â Developing and writing clear explanations and justifications for any new change or update in the dossier
- Â Demonstrating leadership in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines etc.
- Â Demonstrating an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity
- Â Managing & executing of CMC documentation including variations and responses to health authority questions per established business processes and systems
- Â Depending on experience level, mentor newly hired staff or lead a team of junior staff.
- Â Responsible for the preparation and review of the information required for the development of regulatory CMC
- Â Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems
Apply Online
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