Regulatory Affairs Specialist/manager- Levant- 6

16 hours ago

مصر, Egypt Novasyte Full time

Job Overview

Essential Functions:

- Act as a Regional Regulatory Team Lead and strategist on complex regulatory projects, who is able to create and follow through project strategy on country level in Middle east and north Africa region.
- Act as client’ representative in front of health authorities and with different client partners (Agents/distributes) in several countries.
- Prepare, review and submit regulatory documentation (for example: CTD-e-CTD submissions), as appropriate; follow through post approval commitments.
- Establish strong relationships with stakeholders; present regulatory projects and progress, discuss issues and customer comments.
- Act as an Subject matter expert implementing Regulatory knowledge in Quality/ Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing/ Change assessments; or as applicable.
- Up to date with regulatory intelligence information in different health authorities, communicating to clients and working groups to define best strategy and anticipate future trends.
- Understands the Scope of Work, deliverables and management of budget for several given projects and manages workload as appropriate.
- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training/ development/on-boarding and internships.
- Present to clients on complex regulatory processes at large full service bid defense meetings.
- May act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
- Performs other tasks or assignments, as delegated by Regulatory management.

Qualifications:

- Degree in Life science or related discipline is a must. Professional post graduate degree is a plus.
- High English proficiency, French proficiency is a must for north Africa role.
- At least 3-4 years relevant experience in regulatory national and/or regional scope of work.
- Good understanding of the regulations and related guidelines in Egypt, gulf, levant and north Africa region.
- Good understanding of Regulations (Pharmaceutical, OTC, Medtech and Biological is a must).
- Good knowledge of different regulatory dossiers: CTD, e-CTD, NeeS is a must.
- Possesses a specific regulatory or technical expertise.
- Good, solid interpersonal communication and organisation skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Demonstrates self-motivation and enthusiasm; high sense of ownership.

If you think you are able to bring to the role ability to adapt rapidly changing environment, problem solving attitude and constant readiness to upgrade, please apply.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

  • Regulatory Affairs Specialist

    1 week ago

    مصر, Egypt Alcon Full time

    The Regulatory Affairs Specialist is responsible for coordinating various regulatory affairs activities including but not limited to; products submissions, renewals and updates by coordinating between plants and agents and continuously communicating with all parties involved (including governmental and official authorities) to ensure timely submission and...

  • Senior Regulatory Affairs Associate

    1 week ago

    مصر, Egypt Johnson & Johnson Full time

    A global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with healthcare partners to touch the lives of more than a billion people every day worldwide. “By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier lives.” Johnson & Johnson Innovative...

  • Regulatory Affairs Head

    1 week ago

    مصر, Egypt Antal International Full time

    One of the leading FMCGs companies is looking to hire a Regulatory Affairs Head! Key Responsibilities: - You will be managing Quality QPD, IMPD, and HSE - As Regulatory Affairs Head, your stakeholders will be EMPA, HACCAP, ISO and other Food related associations. - You will be responsible for labelling on both levels locally and globally. - Managing the...

  • Regulatory Affairs Scientist I

    4 days ago

    مصر, Egypt Mondelēz International Full time

    **Job Description**: **Are You Ready to Make It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It With Pride.** You execute the regulatory affairs strategy for your respective category or categories and geographical area using your technical and regulatory knowledge. You ensure our policies, regulatory programs...

  • Regulatory Affairs Executive

    4 days ago

    مصر, Egypt Jamjoom Pharma Full time

    As a Regulatory Affairs Executive, you will be responsible for the day-to-day monitoring of the company’s regulatory activities to ensure compliance with all regulations. You will be a key member of our regulatory affairs team, which is responsible for the company’s regulatory processes and reporting of the regulatory activities. **Responsibilities** -...

  • Grcy-0, Regulatory Affairs Senior Specialist

    4 days ago

    مصر, Egypt Merck KGaA Darmstadt Germany Full time

    A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of...

  • Regulatory Affairs Specialist

    1 week ago

    مصر, Egypt Target Recruitment & HR Solutions Full time

    **Job Requirements**: - Pharmaceutical/Science Bachelor’s Degree or any related field. - 1-2 years experience in Regulatory Affairs, preferably with an FMCG/ pharmaceutical company - cosmetics an asset. - Local knowledge of some MENA regulations for cosmetics, medical devices, or pharmaceutical products. - Fluent in French. - Strong verbal and written...

  • Regulatory Affairs Hub Strategy Manager

    6 days ago

    مصر, Egypt Pfizer Full time

    Why Patients Need You The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated...

  • Regional Regulatory Affairs Strategist Manager

    3 days ago

    مصر, Egypt Pfizer Full time

    Identifying Job Information_ JOB TITLE: _Title reflected Pfizer Org Chart_) Regional Regulatory Affairs strategist Manger REPORTS TO: _Manager Title_) Regional Hub Team Lead DIVISION/BUSINESS LINE: Global Product Development (GPD) VERSION DATE: 01-Feb-2019 SUB DIVISION: Global Regulatory Affairs (GRA) DEPARTMENT NAME: Regional Regulatory...

  • Regulatory Affairs Supervisor

    4 days ago

    مصر, Egypt Multicare Egypt for Pharmaceutical Industries Full time

    **MultiCare **Egypt for Pharmaceutical Industries is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, gender identity or expression, age disability, or other characteristics protected by prevailing regulations, practice or customs/traditions. **MultiCare** is a...