Genpact B Pharma & M Pharma Job - Regulatory Affairs Post - Apply

Genpact B Pharma & M Pharma Job – Regulatory Affairs Post – Apply

Genpact is hiring B Pharma and M Pharma candidates. Pharma job opening 2022. Regulatory affairs job opening 2022. Regulatory job opening 2022, Candidates with master’s degree and bachelors degree in pharma may check our all the details on the same below:

Job Title: Lead Consultant – Regulatory Affairs-LIF007298

Qualification B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy

Preferred Qualification

  • Expertise in VeevaVault will be a plus point.
  • Ability to prioritize tasks to meet deadlines and work with team when help is needed.
  • Ability to identify problems and work with team to formulate a potential course of action.
  • Must demonstrate oral and written communication skills and the ability to communicate issues in a succinct and logical manner.
  • Overall candidate should have a decision-making, research and analytics approach and in numbers.
  • Capability to handle multiple priorities and balance work to achieve business goals.
  • Good people and customer handling skills
  • Effective leadership, communication, and interpersonal skills.
  • Adhere to our principles and values.

The candidate should have profound experience in regulatory affairs with must expertise in regulatory affairs for the Pharmaceutical or Biotech industry, and lifecycle document management. Also need

to have good knowledge of ICH guidelines and post-approval submissions and regulations.

Responsibilities

In this role, you will be responsible for:

Consumer CMC:

  • Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations, guidances and defined regulatory strategies.
  • Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.
  • Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
  • Preparation of Quality Overall Summaries (QOS);
  • Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
  • Submission of relevant sections in Annual Reports for US Market.
  • Preparing RA expert response for deficiency letters from various regulatory authorities;
  • Assessment of registration documentation for consumer products as per the current Health Authority requirements.
  • Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.
  • Post-approval submission knowledge for EU markets

Apply Online

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