Regional Regulatory Hub Strategy Senior Associate

2 days ago


مصر, Egypt Pfizer Full time

**JOB INFORMATION**
**JOB SUMMARY**
Summarize the primary purpose & key accountabilities of the job.
- Handle related regulatory strategies for allocated Products, and ensure communication/clarity of regulatory timelines and strategy.
- Single point of contact for global/product strategists, and In-Country Regulatory Team on regional issues to facilitate the best in class support for product registration and product life cycle management activities.
- Responsible for ensuring that regulatory documentation meets relevant regulatory requirements.
- To ensure business continuity between global/product Strategists and In-Country Regulatory Team.

**JOB RESPONSIBILITIES**
Indicate the primary responsibilities critical to the job.
- Maintain effective regional relationship with stakeholders to ensure communication /clarity of regulatory strategy and timelines.
- Assist and liaise with GCMC, global/product strategists, PGS, Submissions Management, In-Country Regulatory, ILG, ALIM, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
- Assist and support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
- dispatch dossiers to In-Country Regulatory.
- Regularly follow up with In-Country Regulatory Team on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.
- Maintain Pfizer systems and databases, and applicable Pfizer policies and procedures.
- Responsible for ensuring product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
- Responsible for ensuring notifications of proposed regulatory changes are communicated to relevant stakeholders in a timely manner.
- Responsible for ensuring that comprehensive records of country requirements (communication of requirements for RRM updates) and regulatory status, are maintained.
- To regularly follow up progress on regulatory submissions with In-Country Regulatory.
- Contributes to the development of filing and approval goals for the region.
- Ensure systems are in place and adhered to, to optimize process efficiency with out-sourced and in-house contractors, where applicable.

**QUALIFICATIONS / SKILLS**
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
- Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential.
- Appropriate Regulatory Experience : 1-3years’ experience
- Proven ability to manage complex regulatory or drug development issues.
- Proven ability to consistently deliver to time, cost and quality standards.
- Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred
- Country/regional knowledge (For AfME only - specifically, MER, NEAR, South Africa, Maghreb)
- Knowledge of drug development practice, rules, regulations and guidelines.
- Technical skills with respect to understanding of CMC submissions, BoH Requirements to identify potential risks
- good communication, negotiation and interpersonal skills
- Strategic thinking
- Change agile
- Analytical thinking
- Detail
- and compliance orientation
- Big picture thinking

**ORGANIZATIONAL RELATIONSHIPS**
Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.
- Reports to Africa & the Middle East (AfME) Regional Hub Team Lead
- Market regulatory teams
- Regulatory Strategists (e.g. CMC, global/product strategists)
- Submissions Management Hub
- Global Registration & Renewal Support (GRRS) teams
- #LI-PFE

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

LI-PFE



  • مصر, Egypt Pfizer Full time

    JOB SUMMARY The Senior Associate is responsible for executing the content management of non-complex Local Product Documents (LPDs), Local Label Documents (LLDs) and Patient Leaflets (PLDs) for nationally registered products for their assigned products across multiple countries/regions. Provides associated labeling support to the rest of the ILG...


  • مصر, Egypt Pfizer Full time

    Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...


  • 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

    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: -...


  • مصر, Egypt Chefaa Full time

    Chefaa, a leading online pharmacy and healthcare platform in the Health, Wellness, and Fitness industry, is seeking a talented and motivated Senior Strategy Associate to join our team. At Chefaa, our mission is to make healthcare accessible and convenient for everyone. Through our platform, individuals can easily order their medications and...


  • مصر, Egypt United Nations Development Programme (Jordan, Regional Bureau for Arab States) Full time

    **Description**: **Background** **Diversity, Equity and Inclusion are core principles at UNDP: we value diversity as an expression of the multiplicity of nations and cultures where we operate, we foster inclusion as a way of ensuring all personnel are empowered to contribute to our mission, and we ensure equity and fairness in all our actions. Taking a...


  • مصر, Egypt Amgen Full time

    **Labeling and packaging activities management for Middle East North African region for Amgen portfolio** - Perform label management within the system from CDS (product core data sheet) update to variation/MAA submission in the region - Ensure delivery of right first time label source text for artwork creation - Ensure implementation of master artworks as...


  • مصر, Egypt Top Business Human Resources Full time

    Job Description: - Coordinate & manage post approval submissions including Marketing Authorization Transfer (MAT) for the group of assigned markets - Develop & manage post approval including MAT plan, strategy, timelines and execution in alignment and partnering with key stakeholders (i.e. PGS, Markets, Clusters, Labeling team, Submissions Management, CMC,...


  • 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 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 Unilever Full time

    Company Profile: At Unilever you are more than your job title, you are part of the world’s most successful, purpose-led business. Work with brands that are well-loved around the world, that improve the lives of our consumers and the communities around us. We produce world-leading brands including Lipton, Knorr, Dove, Axe, Hellmann’s and Omo, alongside...


  • 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 Islamic Development Bank Full time

    SECTION I: JOB PURPOSE This role is responsible for implementing ITFC's strategies for market penetration to provide Trade Solutions in the public sector for the designated region. The public sector comprises sovereign, quasi-sovereign, and state-owned entities. The role is intended to manage client relationships first-hand and oversee the end-to-end...


  • 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 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...

  • Program Associate

    3 weeks ago


    مصر, Egypt Ford Foundation Full time

    Instructions for Internal Applicants: Instructions for Applicants: - 1. If you are just joining our general Talent Pool, click on Get Started in the Introduce Yourself section and please disregard the instructions for applicants below._ Program Associate - Middle East and North Africa Summary Description: The Ford Foundation's office in the Middle East...


  • 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...


  • 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...