Regulatory Services & Trainings
Regulatory affairs (as it relates to pharmaceuticals and biotechnology) encompass the monitoring and certification of all the processes involved in developing, trialling and manufacturing therapeutics, cosmetics, diagnostics or other biotechnology products and services.
Typically this involves liaising with the FDA (Food and Drug Administration), TGA (Therapeutic Goods Administration) EMEA,EDQM and other regulatory authorities to ensure the regulatory compliance of all company activities to enable the shortest possible time between developing a drug and bringing the drug to the market place.
Regulatory Affairs Officers responsibilities include; Liaising with the FDA and other regulatory agencies for related activities; Leading documentation activities and managing the preparation of sections of regulatory submissions; Providing regulatory leadership, consultation and guidance to project team and R&D and Quality groups.
Typically, to work in regulatory affairs requires at least a health sciences degree, while honours and PhD may enable faster career progression and opportunity for promotion. Typically this type of position requires ongoing education through seminars, keeping aware of changes in the field and possibly additional formal education.
On a day by day basis, regulatory affairs officers may be involved in any of the following activities:
- Provide guidance to documentation activities (Create and maintain templates for and assist in writing regulatory papers);
- Manage the preparation and content of regulatory submissions such as IND (investigational new drug), NDA (new drug application), amendments, supplements and annual reports;
- Critical review of regulatory submissions to ensure accuracy, adequacy and conformance to regulatory requirements;
- Coordinate and provide timely responses to questions from Regulatory agencies.
- Work closely with R&D, Quality, manufacturing and clinical supplies group to plan upcoming regulatory submissions;
- Submit / maintain Drug Listings and Establishment Registrations. Review drug labels; Participate in preparation of group/departmental operating policies and procedures;
- Interact with R&D colleagues and participate in project team meetings and provide regulatory strategy for product development;
- Participate in review and approval Specifications and Stability Study Plans for assigned projects;
- Maintain current, in-depth knowledge of regulatory requirements;
- as needed, provide training and/or organize information sessions for R&D colleagues regarding regulations and new guidance;
- supervise and mentor junior members of the group.
Topics include but are not limited to:
- US regulatory affairs: USDMFs& ANDA Dossiers Preparation
- European regulatory requirements: EUDMFs Preparation& EDQM CEP Submissions
- Preparing for FDA meetings
- Post-approval regulatory requirements
- Regulatory requirements for product labeling
- Electronic submissions
- Quality assurance
- Drug development Certificate Program Requirements
- To successfully complete the certificate program, learners must complete 8 Core units and 6 Elective units
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