Regulatory Affairs Manager

In this role Candidate should have experience in regulatory affairs while essential exposure to Structured Product Labelling (SPL) for assigned products and also need to have good knowledge of labelling requirements for USA market. In depth working knowledge of SPL review and submissions.

Responsibilities

Review of SPLs content labelling

Submission of SPLs content labelling

Monitoring of recent updates in SPL

Escalate, notify and resolve any issues that may impact final submission.

End to end responsibility/ management of product registered in USA market.

Responsible for maintaining internal tracker for SPL submissions.

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.