Genpact Hiring 2022 Bachelor’s degree for Lead Consultant – Regulatory Affairs At India-Mumbai . Genpact Notification full details below..Interested and eligible candidates can Apply Now.
- Vacancy details:
- Post Name: Lead Consultant – Regulatory Affairs
- Qualification: Bachelor’s degree
Job Description: Genpact Hiring For Lead Consultant – Regulatory Affairs !
- Important Details :
- Location: India-Mumbai
- Post of date: 18/05/2022
- Selection Process: The selection will be on the basis of Interview.
Roles and Responsibilities
• Leading project teams, ensuring maintenance of team records and process-related documentation i.e process maps, job aids, project trackers, checklists, etc.
• Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products.
• It includes regulatory assessment; preparation and quality review of pre & post approval regulatory submission dossiers; and compliance activities
• Extensive experience in end-to-end life-cycle management of pharmaceuticals for EU, US and ROW markets for a vast range of therapeutic areas.
• Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under direction of team scientists.
• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Ability to lead client meetings and managing project governance.
• Deliver on agreed SLAs with clients at contract and account/ project level. Meet all monthly reporting/business metrics/KPIs requirements and manage internal control processes.
• Planning the project by understanding the client needs, channelizing appropriate resources, managing project deliverables and providing solutions in real time.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Ability to prioritize & execute the project according to the project plan/ timelines/ schedules.
• Ensure established policies and procedures of the organization/client are followed and ensure compliance.
• Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
• Contribute to draft Request for information and/ or Request for proposals for new client/ business opportunities. Provide inputs to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluate supporting documentation to assess acceptability and identify potential risks.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Demonstrated ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
• Demonstrated effective leadership, communication, and interpersonal skills.
Qualifications we seek in you!
Bachelor’s or master’s degree required in science,
Pharmacy or related field (advanced degree preferred) with relevant experience of CMC RA.
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.