Regulatory Affairs Ops Specialist

Individual will be responsible for supporting global regulatory activities relating to specific portfolio of global products/projects with a focus on the United States. Support activities will include regulatory submissions and lifecycle management activities for marketed products with a focus on CMC (Chemistry, Manufacturing and Controls). A solid understanding of global regulatory requirements, strong organizational skills and a proactive mindset to support lifecycle management is a must

Key Responsibilities:

* Manage, compile and author CMC sections (CTD module 3) of marketed product supplements/variations, including eCTD content Winting sections of module 3 in CTD format

* Compile and submit, in a timely manner, regulatory documents according to regulatory requirements

- US submissions to FDA (Prior Approval Supplement, CBE, Annual Reports, ....)

Assist with responses to regulatory agency questions related to CMC content

Maintain regulatory files in a format consistent with requirements

Develop and execute regulatory project plans for lifecycle management

As required, represent regulatory affairs in project team meetings

Other areas of potential support depending on business priorities: lifecycle management through regulatory assessments of manufacturing changes and contribute to regulatory strategy discussions for post approval changes

Education/Experience:

Bachelor's degree or country equivalent in a scientific discipline

* Minimum 5 years' regulatory or equivalent experience within a pharmaceutical company.

CRO, or similar organization supporting Small Molecule products; experience with marketed products preferred

* Familiarity with US FDA/ /ICH guidance/regulatory requirements and submission formats (i.e.

OCTD)

* Demonstrated experience in US submission processes for CMC-related content

* Direct experience with the preparation of Module 3 (eCTD) quality documents for post-approval supplements/variations

Detail/accuracy orientated, collaborative and willing to learn.

Ability to work independently and as part of a team

Technical system skills (e.g. Microsoft Office Tools, familiarity with Veeva RIM is a plus)

Strong writing and communication skills (English mandatory)