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 together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

SENIOR ASSOCIATE REGULATORY AFFAIRS

WHAT YOU WILL DO

In this vital role you will assist in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, and Regulatory Affairs processes and deliverables for the ELI markets Egypt, Jordan, Iraq and Lebanon.
- Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements
- Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and requirements
- Manufacturing site registration and license maintenance
- Responsible for coordinating with the International regulatory team to ensure right first-time dossiers are provided
- Coordinate and respond to the requests by authorities during the evaluation process and check the correct handling of deficiency letter within a specific timeframe in order not to delay MOH approvals
- Monitoring of emerging guidelines and changes affecting business and communication to relevant internal customers
- Providing guidance on the approval processes to internal stakeholders within the region and providing regulatory input for launch planning
- Maintenance of all lifecycle activities/ Product renewal license details by accurately preparing filling submissions and approval within the preset global timelines -accountable for overall accuracy and compliance
- Ensure alignment of regulatory objectives with regional / global regulatory objectives and commercial plans
- Accountable for solving all supply issues related to regulatory activities.
- To provide regulatory intelligence
- Ensure compliance with company's SOPs and working practices for Good Regulatory Practice
- Management of documentation archiving and record keeping according to SOP and local legislation
- Contact for agency interactions for portfolio of products and coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies
- Collate, distribute, exchange and archive regulatory information with colleagues across the business
- Participate in regulatory and affiliate process improvements initiatives
- Review promotion and non-promotion materials to ensure compliance with local license, company procedures and Code of Practice

BE PART OF OUR TEAM

Reporting to the Regulatory Affairs Manager for ELI, you would be joining a team of regulatory professionals passionate about delivering the best outcomes for our medicines to patients.

WHAT WE EXPECT OF YOU

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

- Pharmacy Bachelor’s degree
- 2-3 years of directly related experience in regulatory affairs (ELI markets)
- Knowledge and awareness of the relevant regulatory guidelines and legislation for ELI markets
- Strong communication skills both verbal and written
- Organizational skills & developing regulatory project management skills

WHAT YOU CAN EXPECT OF US

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
- Vast opportunities to learn and Develop
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

LOCATION: Cairo, Egypt

.



  • مصر, Egypt Amgen Full time

    **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 together—researching, manufacturing and delivering...


  • 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 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

    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...


  • 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 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 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 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 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 Hikma Pharmaceuticals PLC Full time

    **Description**: Regulatory Affairs Officer is responsible for performing Regulatory activities to maintain product registrations, product licenses and relevant life cycle management activities within the defined timelines and in full compliance with the legislations and regulations. **Duties & Responsibilities**: - Obtain marketing authorizations and...


  • 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 Hikma Pharmaceuticals PLC Full time

    **Purpose**: Regulatory Affairs Supervisor is responsible for performing Regulatory activities to maintain product registrations, product licenses and relevant life cycle management activities within the defined timelines and in full compliance with the legislations and regulations. **Responsibilities**: - Secure obtaining marketing authorizations of new...


  • 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 Johnson & Johnson Full time

    **Position **Summary**: **The Head of Regulatory Affairs JENA **will be responsible for leading regulatory affairs activities in the cluster for the Janssen portfolio and support the local GPH regulatory team (limited support) as required striving for convergence in ways of working. The JENA cluster comprises Egypt, Libya, Sudan, Ethiopia, and any new...


  • 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...


  • 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 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 Kinetic Full time

    A leading **Medical Device** company is actively recruiting a **Regulatory Affairs and Quality Assurance Specialist for** their **Egypt** office. **The main responsibilities will include but not limited to**: - Enhance and develop regulatory compliance of management system. - Define and execute regulatory plans and manage timelines to achieve the stated...