Regulatory Affairs Pharmacist
il y a 3 jours
At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization.
We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.
About the Role:
We are seeking a candidate for the Qualified Person Role who will be responsible for supporting the transition to legal pharma entity in Morocco. The primary role of the successful candidate will be to prepare and submit the file for the pharma license, to establish the go to market model , to review and QP certify imported/locally manufactured batches in preparation for release onto Morocco market , to supervise regulatory affairs activities with the local authorities , to manage the distribution channel and to carry out associated support activities. The person will also be responsible to support the maintenance of the MIA under which the import and certification activities occur, participating in inspections, executing inspection follow up (CAPA) and supporting inspection readiness activities. The role will also involve oversight of the Quality Management System (QMS). This position will partner with key internal business stakeholders and will work cross functionally on continuous improvement activities to drive effective, compliant, and sustainable solutions. This role demands an understanding of the regulatory requirements governing pharmaceutical products in Morocco.
competencies
- Excellent communication, collaboration, and problem-solving abilities.
- Confident and professional.
- Credible in liaising with clients, customers, suppliers and regulators.
- Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
- Strong analytical and problem-solving skills.
Preferred Skills
- Self-motivated and demonstrated success in working with cross-functional teams.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong supervisory and leadership skills.
Detail oriented with proven abilities to meet deadlines and time management skills.
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