Genpact Mumbai Hiring Lead Consultant – Pharma Regulatory Affairs

Genpact Mumbai Hiring Lead Consultant – Pharma Regulatory Affairs

4 March, 2022

About the job

Responsibilities

  • 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!

Minimum Qualifications/skills

  • 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

Apply through below link

Lead Consultant, Pharma Regulatory Affairs-LIF006862 | Genpact | LinkedIn

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