Genpact B Pharma & M Pharma Job - Regulatory Affairs Associate

B Pharma & M Pharma Job @ Genpact – Regulatory Affairs Associate

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 bachelor’s degree in pharma may check out all the details

Job Title: Lead Associate – Regulatory Affairs-LIF008711

Job Lead Associate

Primary Location India-Mumbai

Job Category Full Time

Eligbility Criteria

• B. Pham/M.Pharm/Science Graduate

• In-depth working knowledge of ECTD types of submission and industry-standard publishing systems.

• Effective time management and organizational skills

• Effectively communication

• Flexibility to adapt to a changing environment

• Good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.

Preferred Qualifications

• Experience in Pharmacy Regulatory Affairs

The Role demands for an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment

Responsibilities

• Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the LATAM and Canadian Submissions.

• Performing final technical quality review.

• Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;

• Performing post-submission processing activities such as receiving acknowledgment from the authority of

submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders;

• Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.
Qualifications we seek in you!

Apply Online

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