Manager Regulatory Affairs
Il y a 3 mois
RA QA Manager - Responsible Person GDP
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
As an RA QA Manager - Responsible Person GDP supporting the Regulatory Affairs and Quality Assurance Team, you will be trusted to work on ensuring compliance with regulatory requirements and maintaining quality standards at our office in Mechelen.
In this role, a typical day will include:
- Collaborating with internal stakeholders and leading multiple regulatory and quality projects.
- Providing support for non-project related “regulatory excellence” activities.
- Performing the role and responsibilities of Responsible Person as laid down in Good Distribution Practices of medicinal products for human use (2013/C 343/01) and Belgian Royal Decree of 14 December 2006, ensuring compliance with all necessary cGMP & GDP regulations and standards related to the distribution of pharmaceutical products.
- Overseeing the registration, renewal, variations, and ongoing regulatory compliance of medicinal product registrations within Benelux (Belgium, Luxembourg, and Netherlands).
- Ensuring compliance with global regulatory requirements and adherence to internal policies and processes.
- Responding to regulatory requests from across the organization in a timely manner.
- Providing high-quality regulatory support for assigned products/projects.
- Partnering with internal stakeholders (e.g., regions) to align on an optimized regulatory strategy to achieve business objectives.
- Reviewing promotional materials for the entire portfolio of medicines and medical devices.
- Developing training programs for internal stakeholders, as needed.
- Creating clear, concise, and complete documents to facilitate reviews/approvals.
- Maintaining processes and procedures needed for an effective Quality System, including self-inspections, supplier qualifications, CAPA process, and SOP compliance.
- Implementing Global Quality System Procedures (QSPs) at the local level and ensuring local work instructions are in place if needed, including adequate training assignments.
- Managing the local deviations process, ensuring adequate quality investigations and root cause determination.
- Participating in audits of GxP suppliers and self-inspection programs, leading external audit preparation activities, and contributing to external audits by Notified Bodies and Health Authorities as needed.
- Ensuring products are received, stored, handled, distributed, and transported according to regulatory requirements.
- Ensuring adequate use of Change Control at the affiliate.
- Providing input into market action decisions, being the local representative of any post-market actions, and promptly executing any necessary market actions for medicinal products as Responsible Person for Alcon Benelux.
- Ensuring customers are approved to receive medicinal products.
- Deciding on the final disposition of returned, rejected, recalled, or falsified products.
- Approving any product returns prior to them being placed back to saleable stock.
- Approving all subcontracted activities that may impact GDP of Alcon’s medicinal products.
- Ensuring all relevant customer complaints are dealt with effectively and in a timely manner.
- Ensuring proper storage, handling, distribution, and transportation of the products in accordance with regulatory requirements.
What You’ll Bring to Alcon:
- Education: Degree in Pharmacy (Responsible Person GDP qualification is required)
- Years of Experience: Preferred 5 years in regulatory affairs and quality assurance within the pharmaceutical or medical device industry, but we are open to other profiles as well.
- Technical Skills: Strong knowledge of GMP, regulatory requirements, and quality management systems. Proficiency in regulatory submission processes.
- Behaviors: Excellent communication skills, attention to detail, and the ability to work collaboratively in a team environment.
How You Can Thrive at Alcon:
- Autonomy: Enjoy a high level of autonomy in managing regulatory and quality processes.
- Challenging Work: Engage in challenging and impactful work that directly contributes to patient safety and product quality.
- Team Environment: Be part of a supportive and collaborative team that values your expertise and contributions.
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