Genpact Sr Regulatory Affairs Associate Vacancy – Apply Online
Genpact Jobs – Pharma jobs M Pharma, B Pharma Sr Associate – Regulatory Affairs Job. Candidates with a postgraduate and graduate degree in pharmacy may check out all the details like a job description, eligibility and all other relevant details below:
Job Title: Sr. Associate – Regulatory Affair-CPG018495
Primary Location India-Mumbai
Master Skills List Operations
Job Category Full Time
Minimum Qualifications
- Bachelor’s degree in pharma / Science
- Strong financial analytical skills and problem-solving skills.
- Effective communicate in writing and verbally to senior management.
- Experience in balancing customer-facing role and work assessments.
- Self-starter and have analytical, problem-solving skills
- Ability to balance customer governance meetings
Preferred qualifications
- Able to nurture robust working relationships with the team, peers and clients, scheduling flexibility required
- Overall candidate should have problem-solving, macro-level research and analytics approach and good in numbers.
- Good people and customer handling skills.
- Effective communication and interpersonal skill.
Responsibilities
The Role demands a highly qualified professional who can provide guidance to direct reports typically comprising of first-line managers and supervisors. The associate will be responsible for all the activities related to –
- Perform document level & submission level publishing, assembly and distribution activities.
- Performing submission readiness checks.
- Compiling SAS and other datasets and non-PDF files.
- Publishing documents for eCTD, NeeS, paper, and other PDF format submissions.
- Performing final technical quality review and technical validation (eCTD/NeeS)
In-depth solid understanding of ECTD/ NEES types of submission, industry-standard publishing systems. - Effective time management and interpersonal skills to efficiently run 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 behaviours 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
Flexibility to adapt to a changing environment, keeping current with new and updated - processes and procedures
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