About the Job

Responsible for managing regulatory activities for lifecycle submissions to US FDA. This includes, but is not limited to the compilation, review, publishing and submission of post-approval (lifecycle) submissions, with a focus on Chemistry, Manufacturing and Controls (CMC), Labeling and Publishing. Required to provide regulatory support in applicable project team meetings and expected to meet all submission timelines to ensure timely and quality submissions to support the business.
 

Key Responsibilities

Regular and predictable attendance and punctuality.

Compiles, reviews and submits lifecycle changes for the US market. Regulatory submissions such as annual reports and supplements for ANDAs and NDAs will be submitted to FDA as per the business needs and compliance with all FDA requirements.

Reviews change controls for regulatory impact and documentation to be included in regulatory submissions.

Works closely with cross-functional departments to provide the appropriate regulatory requirements/guidance, as applicable.

Assists in the development and/or improvement of regulatory best practices, processes, and procedures.

Responsible for publishing documents for submission in compliance with current FDA requirements.  Provides troubleshooting support of technical issues. Provides assistance as needed with document formatting and compliance with required FDA specifications.

Directly interfaces with project teams to manage the preparation of their documents; provides expert publishing assistance for all documents critical to regulatory submissions.  Ensures documents are compliant with Corporate policies and Guidelines, as well as Regulatory Guidances.  Critically reviews submission documentation and provides input to respective departments for necessary revisions.

Other duties as assigned.

 

What We Expect

Bachelor’s Degree in a scientific or technical field

1-3 years of pharmaceutical experience.

Direct regulatory affairs experience is preferred.

Interact with all levels of the organization and facilitate meetings and drive agreement with partners across the business.

Make daily decisions that directly impact the quality of submissions and the overall business. 

Decipher between requiring higher level input and input at the analyst level.

Manage multiple projects and timelines.

Excellent verbal and written communication skills

Thorough understanding and working knowledge of regulatory requirements for post-approval submissions for the US Market.Demonstrates the ability to ensure high quality labeling is generated and maintained

 

What We Offer

A dynamic work environment

Opportunities to interact with colleagues at all levels, as well as clients and customers

30 vacation days per year

Annual health check-up

Monthly food and travel allowances