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Job Description

Responsibilities

In this role, you will be responsible for:

Consumer CMC:

• Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations, guidances and defined regulatory strategies. 
• Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.
• Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
• Preparation of Quality Overall Summaries (QOS);
• Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
• Submission of relevant sections in Annual Reports for US Market.
• Preparing RA expert response for deficiency letters from various regulatory authorities;
• Assessment of registration documentation for consumer products as per the current Health Authority requirements.
• Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.
• Post-approval submission knowledge for EU markets

Additional:

• 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.

Preferred Qualification

• Expertise in VeevaVault will be a plus point.
• Ability to prioritize tasks to meet deadlines and work with team when help is needed.
• Ability to identify problems and work with team to formulate a potential course of action.
• Must demonstrate oral and written communication skills and the ability to communicate issues in a succinct and logical manner.
• Overall candidate should have decision-making, research and analytics approach and in numbers.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Good people and customer handling skills
• Effective leadership, communication, and interpersonal skills. 
• Adhere to our principles and values.