Senior Manager-Regulatory Affairs – at Genpact in Mumbai. Apply Now!
Looking for a rewarding career in regulatory affairs? Genpact is hiring a Senior Manager – Regulatory Affairs (Consumer CMC) in Mumbai, India! This full-time role requires expertise in lifecycle document management (LCM), regulatory submissions, and compliance with ICH and FDA guidelines. If you have a background in pharmacy, medicine, or life sciences, along with team management skills, this could be the perfect opportunity for you. Apply today to join a global leader in digital transformation and professional services!
Job Posting: Senior Manager-Regulatory Affairs (LIF020273) at Genpact
Primary Location: India-Mumbai
Schedule: Full-time
Education: Bachelor’s / Graduation / Equivalent
Job Category: Full Time
Responsibilities:
- Responsible for overseeing the project progress, managing the team, ensuring the project stays on schedule and maintaining communication with stakeholders.
- Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations, guidance and defined regulatory strategies.
- Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data, quality control of the CMC documents ensuring the project meets the goals and standards.
- Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
- Preparation of Quality Overall Summaries (QOS) for drug product and drug substance.
- Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets as Senior Manager.
- 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
Qualifications for Senior Manager:
- Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.
- Mandatory Knowledge of ICH and FDA guideline for global market market.
- Advanced tableau/power bi knowledge needed preferred for Senior Manager.
- Analyzing and mining business data to identify correlations and discover patterns from various data points.
- Should be advance level in English language.
- Facilitate effective communication and collaboration among team members. Provide guidance, support and mentorship to team members.
- Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.
- Ability to identify problems and work with team to formulate a potential course of action.
- 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.
- Must demonstrate oral and written communication skills and the ability to communicate issues in a succinct and logical manner.
- Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions required for Senior Manager.
- 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.
Equal Opportunity Employer:
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability, or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation.
Keywords: job posting, Genpact, regulatory affairs, senior manager, full-time, regulatory strategies, quality documents, qualifications
