Regulatory Affairs Specialist Cmc, Meta

2 weeks ago

مصر, Egypt Acino Pharma Full time

**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 empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

This position is based in **Cairo, Egyp**t and will report directly to the **Regulatory Affairs Manager, META**. The role will be responsible for writing and maintaining all Chemistry Manufacturing Control (CMC) sections of the regulatory files for locally manufactured products within META region, in addition to all relevant processes.

**Your Responsibilities will be**:

- Perform due diligence on Modules 2-5 of the local Regulatory files before new registration or acquisition.
- Advise Business development and other functions on the quality of the Regulatory files before acquisition of molecules/products.
- Write the CMC part of Modules 2, 3, 4 and 5 of the local Regulatory dossiers in CTD/eCTD format in English according to EU/local regulatory requirements, in cooperation with the local manufacturers.
- Collect and compile necessary raw data, documents, and samples (active substance, impurities, and finished product) to be included in the Regulatory file.
- Update and maintain all CMC sections of the Regulatory files in validated systems (Docubridge).
- Perform deep and accurate due diligence on the local Regulatory dossiers within the META region according to internal process/guidance and according to EU/local Region regulatory requirements. Discuss the due diligence outcome and report with all stakeholders and document according to internal guidance.
- Handle variations to the dossier in accordance with the Change Control process in TrackWise system.
- Prepare responses to requests by the Competent Authorities during the evaluation process, and timely handle deficiency letters within a specific timeframe.
- Create and maintain a full up-to-date database and archiving system for tracking the local Regulatory dossiers in the region.
- Effective communication and cross-functional interaction with all involved departments, both on a Regional and Global levels (Regulatory Affairs, Quality Assurance, Quality Control, Clinical, Production area, Medical Affairs, Pharmacovigilance and Business Development).
- Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.

**Your Profile**:

- Bachelor degree in Pharmacy or a relevant discipline
- At least 3 years professional experience in Regulatory Affairs in the pharmaceutical industry (Research and Development, Quality Assurance, Quality Control departments)
- Good understanding of analytical methods for quality control of medicinal products, validation of analytical procedures and validation of technological process, procedures of bioequivalence/clinical trials/biowaver
- Knowledge of the structure and the specifics of formation and functioning of the dossier for medicinal products in CTD/eCTD formats
- Experience in writing and compiling of Modules 2-3 of the Regulatory dossier in CTD/eCTD formats in English, in close collaboration with local manufacturers
- Experience in due diligence of the Regulatory dossier according to EU and local regulatory requirements
- Knowledge of current legislation and corporate requirements governing regulatory activities (registrations, renewals, variations)
- Confident knowledge and power user of specialized regulatory programs and databases
- Ability to maintain a structured documentation and archiving system. High organizational and communication skills

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you.

**Further Information**:

  • Regulatory Affairs Executive

    3 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** -...

  • Regulatory Affairs Supervisor

    3 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...

  • Senior Regulatory Affairs Associate

    2 weeks ago

    مصر, Egypt Amgen Full time

    Career Category Regulatory **Job Description**: HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve...

  • Export & Regulatory Specialist

    2 weeks ago

    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 Affairs Specialist Missa

    10 hours ago

    مصر, Egypt Johnson & Johnson Full time

    **Johnson & Johnson**: 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 well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health...

  • Regulatory Labeling

    4 weeks 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...

  • Regulatory Affairs Specialist

    3 weeks ago

    مصر, Egypt Beyti Egypt Full time

    Serve as regulatory representative to provide technical expertise, risk assessments, and solutions for product labeling, nutrition, and regulatory issues - Help prepare support documentation and regulatory submissions to NFSA and other authorities (Coordinate, prepare, or review regulatory submissions for local, export or imported projects). - Leads or...

  • Associate Regulatory Affairs Mea

    2 weeks ago

    مصر, Egypt Amgen Full time

    Career Category Regulatory **Job Description**: Job Summary: - Labeling and packaging activities management for Middle East North African region for Amgen portfolio - Coordination and execution of Regulatory Affairs processes and deliverables in the local office: publishing, SharePoint maintenance, statistics analysis, reporting. Key Activities: -...

  • Regulatory Scientist Ii

    2 weeks 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...

  • Associate Regulatory Affairs Mea

    10 hours ago

    مصر, Egypt Amgen Full time

    **Job Summary**: - Coordination and execution of Regulatory Affairs processes and deliverables in the local office: publishing, SharePoint maintenance, statistics analysis, reporting. - Labeling and packaging activities management for Middle East North African region for Amgen portfolio **Key Activities**: - Systems Management to deliver both strategic...

  • Senior Customer Marketing Specialist Meta

    4 weeks ago

    مصر, Egypt Talent Pal Full time

    **Design solutions to drive safe living and quality of life**: **Role Objective**: The Middle East, Turkey and Africa (META) Customer Marketing Specialist will serve as a strong support in developing and executing customer marketing initiatives activities across Middle East, Turkey & Africa for Honeywell Building Technologies (HBT) business. **Key...

  • Drug Regulatory Affairs Specialist

    3 weeks ago

    مصر, Egypt Orchidia Pharmaceutical Industries Full time

    **وصف الوظيفة**: **Purpose of the job**: **Primary Tasks**: - Responsible for Pharmaceutical products, Dietary supplement, Medical Devices and cosmetics products in the following areas. - Oversee the regulation process for products requiring governmental or international approvals. - Update licensing and collects information on registration...

  • Ermc Translation Management Associate

    4 weeks ago

    مصر, Egypt Johnson & Johnson Full time

    **About Johnson & Johnson**: Johnson & Johnson is recruiting for an EMEA RMC Translation Management Associate in Egypt. The EMEA Regulatory Management Center (ERMC) is a regional Regulatory Affairs (RA) team responsible for operational regulatory activities, acting on behalf of Local Operating Companies (LOCs). This virtual team is embedded in the EMEA RA...

  • Scientific Affairs Lead, Middle East

    2 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 and are responsible for the regulatory and policy compliance of our portfolio. You advocate...

  • Sr Channel Ops Specialist Meta

    4 weeks ago

    مصر, Egypt Honeywell Full time

    **The Future Is What We Make It.** When you join Honeywell, you become a member of our Global team of thinkers, innovators, dreamers and doers who make the things that make the future. By changing the way we fly, fueling jets in an eco-friendly way, keeping buildings smart and safe and even making it possible to breathe on Mars. **Make the Best...

  • Ra Support Specialist, International Med Devices

    4 weeks ago

    مصر, Egypt NonStop Consulting Full time

    My client will hire a Regulatory Affairs support Specialist within the Regulatory Affairs Medical Devices teams who is looking to expand on regulatory experience within a well-known international company. The company is a well-known industry name so experience here will give you a strong boost to your CV and will provide a different angle in your...

  • Regulatory Affairs Specialist

    3 weeks ago

    مصر, Egypt Sanofi Full time

    JOB PURPOSE: - Manage review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines. KEY RESPONSIBILITIES AND DUTIES: - Manage review and submission of all maintenance activities (renewal & variations) based on company plans and the authority guidelines. - Timely implementation of all...

  • Ra Process

    4 weeks ago

    مصر, Egypt Johnson & Johnson Full time

    Johnson & Johnson is recruiting for a RA Process & Compliance Officer NEMA, to belocated in Cairo, Egypt. **Key Responsibilities**: **Manage the Regulatory Affairs **Process **& **Compliance activities**: - Keep oversight, reporting and support for Labeling management and systems. - Assess and manage development of new business support processes and...

  • Regulatory Affairs Specialist/manager- Levant- 6

    4 weeks ago

    مصر, Egypt IQVIA 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)...

  • Regulatory Affairs Specialist/manager- Levant- 6

    4 weeks 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)...