Genpact B Pharma & M Pharma Job Vacancy – Regulatory Affairs
Are you the one they are looking for? Genpact is inviting applications for the role of Lead Consultant – Regulatory Affairs. Pharma and chemistry job opening 2022. Pharma job vacancy 2022. Pharma regulatory affairs job opening 2022. Pharmacy job opening 2022. Check out all the details
Job Title: Lead Consultant – Regulatory Affairs-LIF007298
Eligibility Criteria:
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.
Additional:
- Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission
- Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously
- Demonstrates deep understanding of the business value of quality and compliance and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables
- Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions
- Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
- Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
- Depending on experience level, mentor newly hired staff or lead a team of junior staff.
- Flexibility in responding to changing priorities or dealing with unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.
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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