Regulatory Affairs Specialist EFA at Abbott Pediatrics

Algiers, Algiers, Algeria -

Full Time

Start Date

Immediate

Expiry Date

17 Jan, 26

Salary

0.0

Posted On

20 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Pharmaceuticals, Compliance, Quality Assurance, Label Development, Market Share, Promotional Materials, Dossier Preparation, Communication, Training, Business Development, Logistics, Clinical Studies, SOPs, French Language, English Language

Industry

Hospitals and Health Care

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 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 The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: EPD Established Pharma LOCATION: Algeria > Algiers : Micro-Zone d'activité Hydra ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 25 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter

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Responsibilities

The Regulatory Affairs Specialist will work with the Regional RA Manager to implement regulatory strategies for new and existing products. They will prepare regulatory plans, maintain compliance with SOPs, and ensure timely submission of regulatory files.