Genpact Mumbai Hiring Lead Consultant – Pharma Regulatory Affairs
4 March, 2022
About the job
- Dossiers preparation in CTD modules & submission
- Post-approval regulations
- 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
- Post-approval submission knowledge for EU markets
- Knowledge of manufacturing documents like batch records, specifications, analytical methods, validation reports, stability data.
- Developing and writing clear explanations and justifications for any new change or update in the dossier
- Demonstrating leadership in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines etc.
- Demonstrating an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity
- Managing & executing of CMC documentation including variations and responses to health authority questions per established business processes and systems
- Depending on experience level, mentor newly hired staff or lead a team of junior staff.
- Responsible for the preparation and review of the information required for the development of regulatory CMC
- 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
Qualifications we seek in you!
- 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
- Good at problem-solving & Decision Making
- Enthusiasm & confidence
- Adhere to our principles and values
- Time Management skills
- Organizational Skills
Apply through below link