Regulatory Affairs Pharmaceutical Products at Genpact

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), renewal, and PSUR: Submission strategy / provide RA Assessment through change management system / CMC Assessment / Timelines / Handling of deficiency letters (DLs)/ 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
• Registered pharmacist in South Africa
• 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

• Enthusiasm & confidence
• Adhere to our principles and values.
• Time Management skills.