Job Description

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 :

• Education: Bachelor’s degree in a scientific or preprofessional field required
• Experience: 2 plus years applicable GMP experience

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