Genpact Regulatory Affairs Job For Pharma
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Job Posting: Senior Manager, Publishing (Submission & Document Publishing)
The Role demands for an experienced Submission Manager with demonstrated ability to execute responsibility in a highly regulated & process driven environment.
Location: Mumbai
Responsibilities:
- Candidate should have extensive experience in the respective field.
- Technical expert on submissions
- Proven capability to manage the operations and team.
- Taking care of administrative responsibilities of team
- Project & resource management
- Team management and team engagement
- Should be technical expert in eCTD/CTD submissions of US/EU/Canada and Row market.
- Hands on experience on submissions
- Capability to trouble shoot technical validation errors.
- Good client communication skills
- Flexible attitude
- Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for Asia pacific, Europe Submissions and US 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 acknowledgement from 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.
- Co-ordinate with client/stakeholders.
Qualifications:
Minimum Qualifications: B. Pham/M.Pharm/Science Graduate
Preferred Qualifications/ Skills
- Technical Expert on submissions and document publishing
- Proven skills to Manage team and resources.
- Handled a direct team of publishers.
- In depth working knowledge of ECTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
- Effective time management and organizational skills
- Effective communication
- Flexibility to adapt to a changing environment.
Keywords: Genpact, Regulatory Affairs, Pharma, Senior Manager, Publishing, Submission, Document Publishing, Mumbai, Technical Expert.
