Regional Regulatory Senior Associate

2 days ago


Mansoura, Egypt Pfizer Full time

Identifying Job Information_

JOB TITLE: Regional Strategist Senior Associate

REPORTS TO: Regional Hub Team Lead

DIVISION/BUSINESS LINE: Global Product Development (GPD)

SUB DIVISION: Global Regulatory Sciences

DEPARTMENT NAME:
International Regulatory Sciences & Policies - AFME

LOCATION(S): Africa Middle East

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.
- 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.
- Ensure systems are in place and adhered to, to optimize process efficiency without-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 AfMe Regional Hub Team Lead
- Market regulatory teams
- Regulatory Strategists (e.g. CMC, global/product strategists)
- Submissions Management Hub
- GRRS

RESOURCES MANAGED

Summary of resources managed.

Not applicable

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



  • Mansoura, 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...

  • Associate

    1 week ago


    Mansoura, Egypt Global Ventures Full time

    Company Description Global Ventures is a Dubai-based, international VC firm backing global-minded founders who are building growth-stage companies, and using technology to transform emerging markets and the world. Our vision is to become a world-class investment platform deploying capital across the Middle East and Africa region. Our portfolio ranges in...


  • Mansoura, Egypt Citi Full time

    **Job Purpose**: The position covers TTS Client Operations and will be responsible for leading & managing approx. 75 Staff. The holder of this job will be a member of the MEA TTS CO Leadership Team, the Egypt Franchise Management team and will interact with various business seniors at Egypt, cluster and regional level. The position will include oversight...


  • Mansoura, Egypt Talent Pal Full time

    **Global University Systems (GUS) **is focused on becoming one of the world’s most dynamic, inclusive, and diverse education organisations. GUS is an international network of higher education institutions, brought together by a shared passion for accessible, industry-relevant qualifications. GUS delivers a wide variety of programmes, including bachelor’s...


  • Mansoura, Egypt Dedalus SA Full time

    Vous souhaitez donner du sens à votre métier ? Vous voulez contribuer à l'amélioration de nos soins de santé ? Alors rejoignez notre équipe! Solution Implementation & Testing Senior Associate


  • Mansoura, Egypt Premier Services & Recruitment Full time

    Job Description & Specification: **ROLE OBJECTIVE** The Corporate Regional Finance Manager is responsible to oversee all financial activities. He is going to be planning, implementing, managing, and auditing the financial strategy of the organization. Additionally, The Corporate Regional Finance Manager will need to advise, consult, and lead organization...


  • Mansoura, Egypt Diversey, Inc. Full time

    Align regulatory activities with countries' leadership and regional marketing. To this end, create a collaborative working environment and have an understanding of regulatory developments in relevant countries. - Ensures that products are authorized in relevant jurisdictions and follows up any issues that may occur in close collaborations with the MEA...


  • Mansoura, Egypt Elastic Email Full time

    **Regional Marketing Lead,** **Egypt** Besides supporting our customers on a daily basis, we also believe that shaping a more sustainable environment is something we should do. That is why we support Ancient Forest Alliance on its mission to protect endangered old-growth forests and to ensure a sustainable, value-added, second-growth forest...


  • Mansoura, Egypt Baker Hughes Full time

    **Sales Manager - Gas Tech Equipment**: **Are you a Sales Manager that is motivated to deliver?**: **Would you like to join our Sales Team?**: As a Digital Solutions business, we provide intelligent, connected hardware technologies to sense, control and inspect assets across many industries. Customers are provided with peace of mind needed to reliably and...


  • Mansoura, Egypt Visa Full time

    Company Description **Common Purpose, Uncommon Opportunity**. Everyone at Visa works with one goal in mind - making sure that Visa is _the best way to pay and be paid, for everyone everywhere_. This is our global vision and the **common purpose **that unites the entire Visa team. As a global payments technology company, tech is at the heart of what we do:...


  • Mansoura, Egypt FlairsTech Full time

    Details Required Experience 3 years Department Software Development and Testing Career LevelSenior Position Location maadi **Skills**: Javascript React Requirements and responsibilities **Responsibility**: - **Follow up with teams’ progress and provides them with mentorship and guidance.**: - **Responsible for delivering solid, modular code for...

  • Legal Asst Paralegal

    3 weeks ago


    Mansoura, Egypt PepsiCo Full time

    **Responsibilities**: 1. Complete and execute all admin assistant duties such as travel arrangements for the entire legal team, power-point presentations, medical insurance, phone bills, drafting and preparing all required documents and work as required. 2. Manage calendar and schedule of the senior. Legal counsel and organize all team meetings and events...


  • Mansoura, Egypt Canonical - Jobs Full time

    Ubuntu strives to deliver the latest-best free software components, in an easy to use and highly reliable form, with long-term security maintenance commitments. We build on the technical excellence of Debian and bring additional focus and shape to the solutions we offer the industry. The successful applicants will be passionate about the future of Java and...

  • Senior Scheduler

    2 weeks ago


    Mansoura, Egypt Decima International Full time

    **DESCRIPTION** Decima International is a professional services company, providing project management and controls services to clients in the United States and the Middle East. Our mission is to become the premier professional services provider across all industry sectors we are engaged in. To accomplish this, Decima International’s founders established a...

  • Senior Brand Manager

    3 weeks ago


    Mansoura, Egypt MaxAB Full time

    Founded in 2018, MaxAB is a rapidly growing food and grocery B2B e-commerce and distribution platform that serves a network of traditional retailers (mom-and-pop stores) across the MENA region. Using proprietary technology, MaxAB offers a transformative pull-driven supply chain and a tech-product that empowers both traditional retailers and suppliers. MaxAB...

  • Sales Cap Associate

    2 days ago


    Mansoura, Egypt PepsiCo Full time

    **Auto req ID**: 279620BR - To ensure all customer orders are received, collated & processed through the system/SAP in line with SLA & KPI’s. - Download MT / Distributor customer orders and input into the Handheld / Backoffice system - Track & keep a check on credit customers' credit limit (e.g. M&P) to ensure smooth dispatches - Update and report on a...


  • Mansoura, Egypt Teradata Full time

    The Senior Test Engineer contributes with the Test Lead in designing the test strategy, test plans, and test case specifications, plans test resources, participates in code reviews, creates or configures the test environment, prepare the test data, writes the scripts that will execute the tests, executes test cases, records test case results, documents and...


  • Mansoura, Egypt RSA Full time

    **Senior Analyst, Revenue Operations - SecurID** As organizations across the globe transform to meet the rapidly evolving demands of the post-pandemic world, cybersecurity has become the bedrock of today’s digital economy. Nowhere is this more critical than in securing the identities of the employees, external users, and customers that drive the modern...

  • Corporate Affairs

    3 days ago


    Mansoura, Egypt JTI - Japan Tobacco International Full time

    Local applicants are welcome Department: Corporate Affairs & Communication Location: New Cairo, Egypt Reporting to: Corporate Affairs & Communication Director Role: Permanent **Corporate Affairs & Communication Manager** **What this position is about - Purpose**: Manage and deliver internal & external communications plans, including media and public...


  • Mansoura, Egypt YourCode Recruitment Full time

    **Senior Ruby Engineer - Ed Tech** **Up to** **€80** **,0** **00** **REMOTE!** The YourCode Group is proud to work with the industry-leading digital credentialing platform! They enable world-class educational institutions, corporate development and certification programs, professional associations and learning management platforms to issue digital,...