Regulatory Affairs Specialist

5 months 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 approvals.
- Put the registration plans from the beginning of registration till launching the products.
- Follow up the post approval activities.
- Ensure fast registration and reimbursement of Alcon products, updating existing files, through continuous coordination between RA teams in Alcon and agents, as well as health authorities.
- Develop and maintain a product database of all Alcon products’ regulatory status in the region and
- Ongoing registration.
- Define the priority of each project (product - market) based on corporate strategy and Regional Specificities.
- Guarantee the best price to achieve the planed profit margin.
- Ensure timely acquisition of finished products conformity sheets issued from NODCAR and accordingly the timely release of the finished product as per marketing plan.
- Complying with global and local regulatory guidelines.
- Guarantee approvals of all types of local and global variations.
- Securing the routinely release of already registered and marketed products.
- To insure compliance with the local M.O.H.
- Supportive aid to DRA team or any other department in Alcon in solving any pending issues with legal department or higher management of central administration of pharmaceutical affairs.
- Support/Lead Head of RA in country/region projects related to the department.
- Establish and maintain good relationships with Ministry of Health, Regulatory authorities and Pharma associations, ensuring optimum visibility and priority to Alcon products registration.
- Control timelines (submissions - approvals
- introductions) to cope with country plans & strategies as well.
- Medical background, preferably pharmcist.
- 3 to 5 years of experience.
- Medical devices regulatory experience is a must.
- Fluent in English and Arabic.
- Based in Cairo



  • مصر, Egypt Johnson & Johnson Full time

    Johnson & Johnson Medtech is recruiting for a** Senior Regulatory Affairs Specialist** to** **be located in Cairo, Egypt. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and...


  • مصر, Egypt Alcon Full time

    Regulatory Affairs Specialist - French West African Countries At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we...


  • 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...


  • مصر, Egypt اورنچ مصر Full time

    About the job Director, Regulatory Affairs **Purpose of the job** Managing the regulatory affairs, overseeing the industry practices & ensure all government regulations being met to support the current and future strategic plans of Orange. **Duties and responsibilities** - Ensure coordination and enrichment of the company's strategic plan. - Provide...


  • 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...


  • 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** -...


  • مصر, Egypt Zoetis Full time

    **Position Summary** Accountable for the achievement of the local affiliate, Cluster and Corporate objectives, in collaboration with the affiliate RA Manager to support in RA Egypt affiliate and Levant region, and provide Regulatory Affairs support to the local affiliate to help the market(s) achieve their revenue and growth targets: - Obtain new product...


  • مصر, Egypt Johnson & Johnson Full time

    **Position Summary**: In this role, you will ensure that J&J's pharma products, processes, and operations comply with all relevant local, national, and international regulations and standards. You will work across the NEMA region which comprises the Near East, Maghreb, and African countries, meaning that your work will span across a whole continent, shaping...


  • مصر, Egypt Acino Full time

    Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region and Latin America, and operate in some of the most dynamic countries of the world. We value courage, commitment, trust and empathy and provide an environment that supports...


  • مصر, Egypt Acino Pharma Full time

    **Cairo, Egypt, Middle East, Turkey, and Africa**: Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region and Latin America, and operate in some of the most dynamic countries of the world. We value courage, commitment, trust and...


  • 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...


  • مصر, Egypt IQVIA Full time

    **Position title**: Manager, Regulatory Affairs, International **Introduction/Purpose** (provide a brief explanation of the purpose of the position) The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register...


  • مصر, Egypt Multicare Egypt for Pharmaceutical Industries Full time

    **MultiCare** is a well-established Pharmaceutical Company with diversified scope in both manufacturing and marketing of pharmaceutical products, supplements, cosmetics and medical devices. **MultiCare** has +22 years of prominent existence in the local market and has almost +66 products marketed and more to come through the pipelines. **MultiCare **Egypt...


  • مصر, Egypt Medtronic Full time

    **Careers that Change Lives** We are a company who inspiring the extraordinary, for more than 70 years, we have led the way with purpose-driven healthcare technology. That history compels us to relentlessly pursue therapies that change lives. The role is opened to continue our daily milestone in serving our patients & partners and give them the highest...


  • مصر, Egypt Zoetis Full time

    **Position Summary**: - Support in Regulatory Affairs and Quality operations in the affiliate, in collaboration with the affiliate RA Manager and Quality Lead; including maintaining an appropriate Quality Management System. - Provide Regulatory Affairs and Quality Operations support to the local affiliate to help the market(s) achieve their revenue and...


  • مصر, Egypt Skretting Full time

    **JOB CONTEXT** The Regulatory Specialist reports hierarchically into the Regulatory Manager and may have a regional or global scope. **KEY ACCOUNTABILITIES** **Regulatory and Compliance Management** Investigate all kinds of incidents and reports and provide expert advice to more senior colleagues. Minimize risk exposures and ensure adherence with...

  • Regulatory Labeling

    5 months ago


    مصر, Egypt Johnson & Johnson Full time

    Johnson & Johnson is recruiting for a Regulatory Labeling & Compliance Specialist, located in Cairo, Egypt. **Key Responsibilities**: - Perform labeling and artwork activities: create and update labeling documents, annotate artworks, perform proofreading, coordinate labeling submission and implementation, follow up on approvals and implementation...


  • 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...


  • مصر, Egypt Takeda Pharmaceutical Full time

    **_ OBJECTIVES:_** - Responsible for directing all day to day regulatory affairs activities in the assigned countries within Oman, Bahrain & Qatar countries to ensure compliance with all regulations. - Implements regulatory strategies for the earliest possible product approvals and ensures the timely creation, preparation, and achievement of organized valid...

  • Regulatory Scientist I

    5 months 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...