Regulatory Affairs Specialist EFA & Tunisia
Abbott
**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
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