Regulatory Affairs Supervisor

2 months ago


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 for Pharmaceutical Industries is the manufacturing facility is located at the Industrial Zone - New Cairo and its HQ at New Cairo as well. We are one of the fast growing Pharmaceutical Companies in the market which has strong ambition and aspiration to be one of the key players not only in Egypt but also within the region.

Our international alliances are effective in different countries, including Saudi Arabia, United Arab of Emirates, India and New Zealand with future aspiration to extend more business associations and affiliations in near future to further markets. Recently Multicare Poland has been launched which will be the entry port of the business to the European Union (EU).

Vacancy:

- Designation: Regulatory Affairs Supervisor
- Location: Industrial Zone, third Settlement, New Cairo
- Grade: RA01/RA02
- Reporting: Regulatory Affairs Manager

Job Purpose:
We are seeking a Regulatory Affairs Manager to provide support as we expand our product line. In this role, your primary responsibility is to oversee regulatory submissions, ensuring they are compliant with prevailing regulations as well as the guidelines set by other relevant regulatory bodies. You will also assist with external audits and respond to any complaint documentation regarding Multicare's portfolio

A. Essential Duties and Responsibilities:

- Contribute to the formulation and execution of regulatory strategies for Multicare's portfolio, proactively seeking innovative and rapid path to market. Use internal and external networks to ensure regulatory strategies are robust and keep pace with the regulatory environment
- Act as one of the RA advisors on the applicable regulations that govern products in remit, provide guidance and considering all possible interpretations and regulatory pathway
- Provide Regulatory Affairs program governance, administration, business attestation review, metrics/reporting, and training
- Manage, maintain and communicate relevant policies, standards and procedures
- Communication with responsible regulatory authorities (national/international) as well as with notified bodies
- Ensure that a company's products comply with the regulations of the regions where they want to distribute them
- Provide support for all external audits Accountability, including audit corrective and preventive action plans (CAPAs).
- Collect, collate and evaluate scientific data from a range of sources
- Prepare submissions of license variations and renewals to strict deadlines
- Project manage teams of colleagues involved with the development of new products
- Negotiate with regulatory authorities for marketing authorization
- Take part in the development of marketing concepts and approve packaging and advertising before a product's release
- Act as the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of products
- Examine the conformity (all documents for approval must be compliant to all relevant regulations, rules and standards) and taking part in the conformity assessment procedures with coordination of all concerned departments
- Enhance existing engagement model and serve as a trusted business partner representing the Regulatory Affairs organization to business functions, business lines, and other stakeholders
- Act as internal advisor on existing and emerging trends for products/categories in remit. Anticipate threats and opportunities. Interpret regulatory actions and provide the business and R&D with robust analyses and recommendations for action

B.Qualification/Knowledge/Experience:

- Level of education: Life Science Degree (Pharmacy, Veterinary or Science)
- Experience: ≥ 3-5 years work experience in Regulatory Affairs function within pharmaceutical sector
- Language: English proficiency is mandated
- IT Literacy: Professional MS-Office knowledge

C. Competencies and Behaviors:

- Professional networking and MoH access
- Ability to work under sustainable pressure and handling of simultaneous tasks to meet timeline
- Strong planning and organization capabilities
- Ability to influence, convince and persuade
- Strong sense of accountability and autonomy
- Negotiation skills
- Must be flexible and adaptable to change

What we offer:
With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to l



  • 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 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 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 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 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 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 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 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 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 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 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 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...


  • 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 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 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...


  • 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...