R533354 Senior Specialist, Regulatory Affairs

Job Description

Responsibilities :

• The Senior Specialist is responsible for all Regulatory Affairs submission requirements for their assigned product portfolio as applicable. He / she is the regulatory contact with local stakeholders and headquarters (HQ) and is the direct contact for health authority submission specific topics.
• The Senior Specialist also acts as the regulatory relevant License Holder for the company (eg. License To Operate).
• The Senior Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.
• The Senior Specialist is also responsible for other activities (as delegated / assigned by their manager).
• Assists in development of product registration plans and strategies and working cross-functionally to review and communicate the registration strategy with management oversight.
• Assists in timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers including but not limited to variations, renewal applications and supplemental marketing authorization in accordance with local regulations and global standards.
• Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements
• Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventive actions (CAPAs) locally for non-compliance issues.
• Supports local PV audits and inspections including readiness activities and response to findings / observations.
• Participates in and supports audits of contractual partners / vendors as necessary.
• May be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.
• Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality RA data and evaluate processes for potential improvement in efficiency and effectiveness.
• Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
• Supports training of local company staff, distributors, vendors, business partners including training documentation
• Contributes in the maintenance of regulatory licenses including, but not limited to, product licenses, import and distribution of pharmaceuticals and medical device.
• May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with Head Quality Assurance to avoid supply constraints and ensure constant audit-readiness.
• Liaises with the local business units to keep them apprised of safety activities and provide strategic decisions (i.e. product launches, clinical trials) with management oversight.
• As delegated, ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.