Responsibilities include :

Prepares global regulatory documentation and registration in support of customers and SPL business objectives.
Prepares and maintains Drug Master Files (DMF) for U.S. FDA.
Keeps with current EC drug substance or Active Pharmaceutical Ingredient (API) regulatory requirements.
Keeps current on U.S. FDA cGMP requirements.
Keeps current with Code of Federal Regulations (CFR) requirements for applications to DMF, IND and NDA documents.
Participates and supports customer and regulatory agency inspections.
Responsible for reviewing Quality Systems documents such as Change Controls and assessing applicability to the RA department.
Assists with reports and recommendations supporting updates and changes to evolving regulatory requirements.
Independently organizes, manages and meets critical timelines for regulatory activities.
Responsible for using electronic submissions formats such as Electronic Common Technical Document (ECTD).
Possesses good computer skills and apply this knowledge to new applications as needed.
Critical thinker with attention to details and the ability to articulate regulatory position or opinion to others in multi departmental meeting.
Maintains knowledge about regulations and regulatory trends for the U.S.A, Canada and EC.
Maintains knowledge about USDA importation and exportation requirements.
As needed assists with Annual Product Reviews (APR) and ensures correct information is captured in the regulatory files.
Performs other duties as assigned.

Job Requirements and Qualifications :