Regulatory Affairs Specialist EFA
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Job Description
JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare company committed to helping people live not just longer but better. We employ around over 100000 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 teamsproviding 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.
- 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 on Facebook at and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
Algeria > Algiers : Micro-Zone dactivit Hydra
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 10 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Unclear Seniority
Employment Type
Full-Time
