The Regulatory Affairs Specialist will need to ensure Change Controls are in Compliance with Good Manufacturing Practices and documentation related to Quality Systems activities is complete and conforms to all Patheon Standard Operating Procedures (SOPs). Maintain Regulatory Licenses and registration for US FDA and other Regulatory agencies outside of the US. Maintains site Master File. Coordinates all data to support Registrations with the Regulatory agencies that products are marketed. Reviews Batch records, Package Records and Specifications to assure compliance with Registrations. Provides support for client Annual Report submissions as requested.
**Essential Functions: (UP TO 10)**
Interacts with various groups to obtain timely and correct information in order to prepare Change Controls and associated documents to meet schedule requirements. Adherence to schedule timelines as priorities change.
Identify missing or inadequate information. Sorting differing information and ascertaining which is correct.
Assures changes are within Regulatory requirements and works with Clients to assure changes are made within the requirements of the submission.
Collects and reviews all data for use in submissions.
Reviews all submissions from clients for accuracy and completeness
Maintains submission information for easy retrieval
Address requests for certificates and regulatory updates
Respond to requests from Regulatory agencies for information either directly or through Client.
Provides technical advice to Clients regarding deficiency letters and other Regulatory issues.
Annually assembles history of changes to Batch and Packaging Records, Raw material specification, Packaging commodities and Product testing and Specifications for us in the Annual report. A package is developed for each product on an annual basis
Bachelor of Science (B.Sc) in Chemistry, Biology, Microbiology or related field
Minimum 7 years of experience in Pharmaceutical Manufacturing, Quality Assurance and or Product Development.
Equivalent combinations of education, training, and prior work experience may be considered.
+ Knowledge of Good Manufacturing Practices, GLP, EU Good Manufacturing Practices and FDA and the ability to recognize non compliance with these regulations.
+ Ability to read, understand and interpret regulations from a variety of sources.
+ Prior demonstration of attention to detail
+ Strong analytical ability.
+ Ability to handle and be responsible for sensitive and confidential information.
+ Ability to influence others to meet schedule requirements
+ CRO lead Training.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.