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Lead consultant, Regulatory Affairs Pharmaceutical

3 months ago

Mumbai, Maharashtra, India Genpact Full time

With a startup spirit and 115,000 + curious and courageous minds, we have the expertise to go deep with the world's biggest brands—and we have fun doing it We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We're 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're 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 a Lead consultant, Regulatory Affairs Pharmaceutical
You should have minimum years of experience in regulatory affairs with must knowledge of current regulatory guideline in South Africa Market.

Responsibilities
In this role, you will be responsible for all local regulatory affairs lifecycle management (LCM) and maintenance activities for assigned products, including but not limited to the following:

• Variations (Administrative, Labeling, CMC, Safety, dossier harmonization): Submission strategy / provide RA Assessment through change management system / CMC Assessment / Timelines / Management of local RA requirements including implementation tasks (e.g., including grace period for supply continuity), example external compendia. Coordinate artwork changes for submission and implementation (triggered due to LCM activities). Communicates & collaborates effectively with different groups both on the business & IT side, including senior stakeholders – ability to articulate complex scenarios succinctly and targeted to the group

• Update Local PI

• Primary contact for Local Health Authority on delegated products

• Ensure customer success throughout the engagement

Qualifications we seek in you
Minimum Qualifications

• Bachelor's degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.

• Mandatory Knowledge of EMEA/South Africa regulation and well adheres of English language

• 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

Preferred Qualifications/ Skills

• Bachelor's degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.

• Mandatory Knowledge of EMEA/South Africa regulation and well adheres of English language

• 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