Director Regulatory Affairs, Quality Assurance and

vor 15 Stunden

Basel, Schweiz BeiGene Vollzeit

General Description:
Under the direction of the General Manager Sub Region Europe, this individual is responsible for the local representation of regulatory affairs and quality assurance in SRE. The incumbent provides dynamic leadership, strategic direction and close oversight of all regulatory affairs and compliance activities in SRE across BeiGene's portfolio and throughout the clinical development and post-marketing phases of the life cycle.

This job description provides the broadest description of potential assigned activities for this role at BeiGene:
Local responsible person for regulatory affairs:

- Local regulatory contact person MAH to the health authorities in Nordics, Netherlands, Switzerland & Poland and local supervisory authorities
- Support of Regulatory Affairs Europe and Quality Affairs Europe on European projects
- Review and approval local versions of SmPC, labels and package leaflets
- Provide responses to regulatory agencies regarding product information or issues
- Train staff in regulatory policies or procedures, support local compliance activities
- Define and execute approved strategy for distribution licensing and maintenance: Supervise activities relevant for licensing and be responsible for all registration files. Supervise all maintenance activities, including withdrawals.
- Coordinate internal discoveries and depositions with legal department staff
- Develop and maintain standard operating procedures or local working practices
- Establish local regulatory priorities or budgets and allocate resources and workloads
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Manage activities such as audits, regulatory agency inspections, or product recalls
- Formulate or implement local regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products
- Communicate regulatory information to multiple departments (Medical, Market Access, Customer Engagement etc.) and ensure that information is interpreted correctly
- Develop local regulatory strategies and implementation plans for the preparation and submission of new products
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary
- Monitor emerging trends regarding industry regulations in SRE markets to determine potential impacts on organizational processes
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
- Monitor local regulatory affairs trends that are related to environmental issues
- Any other local regulatory activities

Local person for Quality Assurance and Quality Compliance:

- Local contact person representing BeiGene (MAH) to the health authorities (where applicable). Delegation of communication to local Health Authority in case of recall by EU QP
- Review and approval of local artwork (product and promotional)
- Support/Lead External and Internal Audits on behalf of Global Quality or EU Qualified Person/Swiss Responsible Person
- Support Quality Europe in European / Regional Projects
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Management of country related deviations, complaints, Temperature Excursions and Change Controls in alignment with EU Qualified Person/Swiss Responsible Person
- Oversee and maintain country specific QMS activities on behalf of Head Quality Europe (where applicable)
- Quality contact person for any country specific issues on behalf of Head Quality Europe
- Own country specific QMS activities on behalf of Head Quality Europe (where applicable)
- Ensure Quality oversight of training of the personnel of the affiliate
- If applicable notify Health Authorities and Head Quality Europe of batches to be distributed in the country
- Perform audit, review, and approval of local customers in alignment with Head Quality Europe and Global Quality
- If applicable act as Responsible Person in country (France as Pharmacien Responsible and Portugal, otherwise not applicable) or EU GDP RP (DE, NL, ES, IT) and maintain continuing professional development necessary to retain qualification/authorization as RP, according to local regulations.
- Perform Quality Oversight of Free of Charge Samples. This includes but is not limited to: maintaining a register of free samples provided to physicians and reporting this to the local au

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