Global Regulatory Compliance Specialist
This is a pivotal role that demands exceptional expertise in ensuring the integrity of pharmaceutical products across international markets. As the creator and leader of global partnerships within the pharma industry, we strive to be at the forefront of innovation, working tirelessly to bring life-changing therapies to patients worldwide.
Responsibilities:
* Strategic Supervision: Execute close expert supervision within the firm to maintain safety and product integrity at all times.
* Technical Oversight: Directly supervise facilities and ensure compliance with Art. 23 of the Medicinal Products Licensing Ordinance (MPLO).
* Regulatory Compliance: Ensure adherence to Swiss GMP/GDP requirements and regulatory standards.
* Deputization: Designate adequately qualified specialists to deputize in case of absences.
* Instruction Issuance: Issue instructions within the scope of activity.
* Cease Operations Notification: Notify Swiss medic in case of facility closure.
* Independent Decision Making: Make independent decisions without management influence.
* Quality Management System Oversight: Oversee the company Quality Management System (QMS) and ensure compliance with quality system requirements.
* Procedure Maintenance: Maintain and approve Quality system procedures.
* Accessibility: Ensure RP or deputy accessibility by Swiss/Cantonal/Regional Authorities.
* Manufacturer Authorization: Ensure manufacturers have equivalent country Manufacturing Authorizations.
* Audit Requirements: Establish Technical Agreements or Quality Agreements between the company and distributors.
* Trade Restrictions: Adhere to trade restrictions as per 812.21 Swiss Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA).
* Training and Documentation: Conduct employee training per EPM-SOP-QA-002 and maintain Good Documentation Practices.
* Batch Recall Procedure: Establish an effective procedure for batch recall of medicinal products.
* Document Preservation: Collect and preserve documents for proving pharmaceutical quality.
* Supplier Qualification: Regularly qualify suppliers and customers.
* Authorization Verification: Verify supplier and customer authorization to carry out relevant activities and comply with relevant standards.
* Storage Conditions: Ensure storage conditions remain within manufacturer-determined limits during transport.
* Supply Chain Verification: Verify finished product supply chain back to the original marketing authorization holder/manufacturer.
* Falsified Product Identification: Immediately inform authorities of identified falsified or suspected falsified medicinal products.
* Recall Procedure: Establish a procedure for recalling medicinal products.
* Inspection Readiness: Ensure inspection readiness.
Requirements:
* Educational Background: Master's degree in science or equivalent.
* Experience: At least 5 years' experience as RP/FvP, ideally for a Trade Abroad License.
* GDP and GMP Knowledge: Strong understanding of GDP and GMP principles.
* Communication Skills: Excellent written and verbal communication skills.
* Language Proficiency: Fluent German and English language proficiency.
* Auditing Experience: Auditing experience, certified auditor preferred.
* Interpersonal Skills: Excellent interpersonal skills and ability to build professional relationships.
* Dynamic Environment: Ability to work effectively in dynamic environments.
* Critical Thinking: Strength in critical thinking, problem-solving, and decision-making.