Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

Inviting applications for the role of Regulatory Affairs Specialist

In this role Candidate should have experience in regulatory affairs while essential exposure to the lifecycle document management (LCM) and also need to have good knowledge of ICH guideline and regulatory guideline for LATAM markets. In depth working knowledge of DMF, renewal, labelling and CMC variations. LATAM post approval submissions and expertise in designing regulatory strategy and decision with respect to CMC filing.

Responsibilities

• Variations (Administrative, Labelling, 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 / Skills

• B. Pharmacy
• M. Pharmacy

Preferred Qualifications/ Skills

• Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.
• 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.
• 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.