Tunis, TUN
16 hours ago
Regulatory Affairs Specialist EFA & Tunisia
**About Abbott** Abbott is a global healthcare company committed to helping people live not just longer, but better. We employ around over 100,000 people in 150+ countries with a diverse portfolio spanning pharmaceuticals, nutrition, diagnostics and devices. At Abbott, you have the opportunity to make a positive impact on the world through challenging and rewarding work as part of a highly successful and trusted organization that is shaping the future of health. Realize your potential! **CORE JOB RESPONSIBILITIES** Work with Regional RA Manager to implement regulatory strategies on the short, medium and long term by adding new products to our portfolio and maintaining existing ones. + Work with business development and Marketing to set appropriate regulatory strategies on the short, medium and long term by adding new products to our portfolio. + Prepare regulatory plans and ensure their implementation to achieve long term objectives for products that can be qualified in term of sales, market share and profit contribution goals. + As area label coordinator, work closely with different manufacturing sources QA and label development to get labels developed, approved and implemented as per the time frame agreed with management. + Work closely with logistics department to organize timely sample delivery + Prepare regulatory dossiers for new product, renewal and variation dossiers preparation + Work closely with the marketing and medical department to review and approve the promotional materials per the agreed guidelines & within the required timeframe. + Work with GPRA for new products, renewal and variation dossiers preparation + Maintain effective communication with the local representatives and MOH officials + Submission of regulatory file in Tunisia and interactions with HA **Compliance** + Accountable for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs. + Ensure compliance with Corporate and Divisional Standard Operating Procedures SOPs, Good Clinical Practice, and local regulatory requirements pertaining to the conduct of clinical studies. + Relay Abbott Corporate values – train new recruits **Quality** + Ensure compliance with quality SOPs and regulatory requirements in the area of responsibility. + Ensure Training is completed as Planned. **Key Success Factors:** + Registering & life cycle management- registration of new products and managing existing portfolio within changing & challenging regulatory environment. + Business Support-liaises proactively with the functions and participate as a member of cross-functional delivery teams,providing regulatoty advice on simple regulatory issues + Systems and procedures-Ensure appropriate archiving of regulatory dossiers, documents as per global and local procedure. + Submission to Has of promotional and non-promotional activities/symposia/congresses. + Ensure close follow-up and effective implementation of regulatory compliance procedures. **QUALIFICATIONS** Pharmacy Degree Experience: + Minimum 3 years of relevant experience. + Solid pharmaceutical experience, including significant regulatory Affairs + Experience multi-national exposure Fluent French language, in addition to English. Arabic a plus. **Apply Now** + Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. + Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
Confirmar seu email: Enviar Email