Middle- East Africa – Labeling and Artwork Hub Lead

16 سبتمبر، 2022

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Middle- East Africa – Labeling and Artwork Hub Lead
This job is available in 3 locations Full time Regular JOB DESCRIPTION Job Description
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!
The project lead will manage new product launches across EEMEA and support Infertility business in Africa. Pharmacist, Medical Doctor or science based education, with at least 10 years of experience in project management and regulatory affairs, cross functional and cross regional responsibilities.
Position Overview – Basic Functions & Responsibility

Essential functions include, but are not limited to:

Handles E2E implementation as per guidelines for the Middle East Africa region.

Ensures timely, accurate and compliant labeling review and artwork preparation.

For assigned products and tasks, stays updated on late pipeline filings, relevant regional and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.

Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.

For assigned products and tasks, works alongside the BD, locally, regionally and globally, to support business initiatives in sub region.
Applicable to incumbent with direct reports only: Responsible for people management of applicable Labeling personnel in Country and provides clear leadership for these. Secures appropriate career development for the applicable staff and is responsible for keeping the applicable staff scientifically and legally updated within the Regulatory area.
Major Activities

Major activities include, but are not limited to:

New Product Registrations

Performs timely and correct new product packages to support submission in MEA/ EEMEA countries

Participate in New Product Launch discussions and planning for MEA/ EEMEA countries.
Maintenance of Registered products

Ensures that needed labeling support is provided to all ongoing maintenance activities for registered products in the Middle East Africa.

Participate in planning of products variation as per E2E guidance.
Compliance:

For assigned products, ensures timely reviewing preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to Organon and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.

Ensures that all internal customers receive relevant information with regard to the Labeling status of the assigned products.

Ensures the correct and proper utilization of GLAMS to generate mockup artwork and to implement revisions to artwork.

Ensures efficient and consistent implementation and use of internal and external Labeling databases and systems in the country.

Ensures that files and archives related to Labeling are kept updated and complete.

Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.

Participates in implementation of updated regulatory/labeling documentation according to Agency requirements and in-house guidance.
Labeling and artwork:

Ensures high quality review and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents.

Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.
Cross-functional activities:

Ensures adequate support to other functions to enable compliance in areas related to labeling, such as and supply maintenance.

Secures timely and adequate information and decision making with regard to Labeling issues that need to be brought to the attention of the Management Team, such as Supply issues and labeling changes.

Takes part in subsidiary product and launch teams to provide Labeling input and strategy advice.

Participates, provides active input and lead if the case the local Medical Governance.
Regulatory environment:

Keeps abreast of local and international laws.

Participates in internal registration managers' meetings at sub-regional and regional level and EEMEA regulatory workgroups on selected issues.

For new regulations, identifies and tracks changes/trends that might impact Organon business.
Manage direct report, as applicable:

Sets up priorities, organizes, oversees and monitors direct report's activities, towards division's and country's objectives achievement in compliance with policies and standards.

Ensures that direct reports are trained for their proper use of internal regulatory systems.

Through attendance to courses/workshops ensures that staff is appropriated updated on new legislations, requirements on Regulatory.
* Manages, coaches, and develops talent. Maintains a scientific knowledge and expertise.
Fosters a positive team spirit of the staff.
LOCAL REQUIREMENTS, as applicable
Active participation in local new regulations, changes with regards to labeling/artworks.
Skills Required:
Must be hold a B.Sc degree in pharmacy or other life sciences. A minimum of 5 years experience in a Registration Department or equivalent, which should include dealing directly with regulatory, supply& demand, and manufacturing related activities. The incumbent must be familiar with local and regional legislation procedures and guidelines governing pharmaceutical products.
Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills. The incumbent should possess a meticulous attention to detail, and be flexible enough to successfully handle conflicting time pressures and a large volume of work. A mature and disciplined approach to work is essential as is the ability to coordinate the work of others. The incumbent should be able to demonstrate agility and assertive skills in dealing with internal and external parties. The incumbent must demonstrate proficiency in English language (leverage French, Arabic and African) as well as PC use with regard to word-processing, spreadsheets, database application, and internet.
For seniority, a minimum of 5 years experience in a Registration Department, dealing with most aspects of registration and experience in managing others. A sound appreciation of the interactions and relationships of the dept. with other groups internally is expected. Must have client oriented approach and work according to the Organon leadership vision.
Location is flexible within EEMEA.
Who we are…
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the