Job Description

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world\xe2\x80\x99s biggest brands\xe2\x80\x94and we have fun doing it. We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We are harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we are calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower.

Welcome to the relentless pursuit of better.
Inviting applications for the role of Lead Consultant - Change coordinator, Pharma Regulatory Affairs

GRA complete spectrum of regulatory and post-approval services include variations, RFI, RUP, MAA, Renewals, and gap analysis. Driving transformation and improving regulatory compliance with domain expertise and digital technology
You should have more extensive experience in handling post approval maintenance and change management activities. Proven experience of handling complex market submissions for global markets including EU. Proven capabilities of project management including planning and execution of several regulatory projects. Thorough knowledge of ICH and post approval guidelines.

Responsibilities:
The Role demands for a self-driven Individual contributor /Team Lead, who will be responsible for all the activities related to \xe2\x80\x93

• Identifying changes and their impacts, planning for, and assessing impacts of the change.
• Defining and implementing change management activities.
• Participating in evaluating proposed changes.
• Documenting proposed changes their impacts and resolution.
• Responsible for regulatory writing for Module 3 and CMC documents.
• Responsible for handling CMC post approval changes such as variations, RTQs, renewals, baselines for a vast range of product portfolios and markets, Dossiers preparation in CTD modules & submission
• Post-approval regulations
• Knowledge of manufacturing documents like batch records, specifications, analytical methods, validation reports, stability data.
• Developing and writing clear explanations and justifications for any new change or update in the dossier
• Demonstrating leadership in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines etc.
• Depending on experience level, mentor newly hired staff or lead a team of junior staff.

Requirements

• Excellent Verbal and Written communication skills
• Ability to transfer knowledge
• Ability to engage with people immediately & build Relationship
• Team Management skills and proficiency
• Good client communication
• Basic project management skills
• Mentoring junior team members

Key Attributes

• Good at problem solving & Decision Making
• Enthusiasm & confidence
• Adhere to our principles and values
• Time Management skills.
• Organizational Skills

Qualifications
Minimum qualifications
B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
Preferred Qualifications / Skills
Self-starting ability, Multitasking, Decision making

Location
Mumbai

Shift
Day Shift

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 diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com . Follow us on Twitter, Facebook, LinkedIn, and YouTube.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a \'starter kit,\' paying to apply, or purchasing equipment or training.

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