Job Description

We are looking for candidates to be based out of Gurugram for Shared service center for a leading pharmaceutical organization.

Person will be working on rotational shifts (2 PM - 11 PM, 3 PM -12 AM) and will be expected to come to office for 1-2 days.

Enclosed are the key responsibilities :

- Ensure your team prepares, coordinates and submits in line with the provided requirements the applications for Variations and Renewals to authorities (regulatory agencies) within agreed timelines and in accordance with agency requirements

- Manage and prioritize your team\'s workload in accordance with the expectations of the associated Business Unit and/or Market Unit(s)

- Oversee the preparation and filing of high-quality submissions to regulatory authorities

- Ensure all applications are filed in accordance with predetermined timelines

- Provide expert regulatory strategy/guidance to your team in alignment with the associated Business Unit and/or Market Unit

- Develop staff to continuously improve the performance of your team

- Maintain regular contact with peer(s) in the associated Business Unit and/or Market Unit(s)

- Align with other Team Leads in the Shared Service Center to ensure consistency of approach and methodology across delivery teams

- Ensure day-to-day delivery of expected services at agreed upon service levels and at budgeted cost

- Ensure timely resolution of issues and escalation topics within your team

- Escalate when needed systemic performance, delivery, and process issues

- Support technical troubleshooting to ensure issues with submissions are resolved and deadlines met

- Implement the necessary improvement opportunities in alignment with the Global Process Owner (GPO), the SSC Lead, and the associated Business Unit and/or Market Unit(s)

- Maintain current knowledge of Agency requirements for regulatory data management, and regional formats and standards; ensure compliance within your team accordingly

- Act as point of contact within the organization for the delivery team for any requests and questions.

QUALIFICATION AND WORK EXPERIENCE:

- Bachelor\'s degree in Life Sciences or related scientific field; certificate in Regulatory Affairs beneficial

- 10 years of experience in Biologics, biopharmaceutical world. Any experience in biosimilar is a plus, from which at least 5 years in managing teams

- Extensive experience in Regulatory Affairs

- Fluent in English (written and spoken)

- Knowledge of regulatory affairs of US market.

REQUIREMENTS / KNOWLEDGE TO FULFIL THE POSITION:

- Proven Regulatory Affairs knowledge and experience in preparing and filing of Renewals and Variations with different Health Authorities.

- Thorough understanding of Agency guidelines and cGMP\'s, as they pertain to Biologics (Biosimilars being a plus).

- Strong communication skills across all levels and across geographies

- Prior working experience in Shared Service Center preferred

- Ability to manage multiple demands on time and work with cross-functional teams in an international environment

- A collaborative, solutions-oriented approach and strong analytical skills

- \'Can do\' attitude with a practical approach to problem solving

- High level of commitment

- Excellent attention to detail

- Strong Customer orientation

- Excellent English fluency (spoken and written)

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