Job Description
Position Overview - Basic Functions & Responsibility Essential functions
include, but are not limited to:
* Lead and coordinates E2E process for new product launches as per guidelines for the EEMEA region.
* Supports timely and compliant new introductions
* 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.
* Leads and supports people into developing new products ' introduction strategy and up to supply/ cross functional launch plan and provides clear leadership for these.
Major Activities Major activities include, but are not limited to:
New Product Registrations
* Performs timely and correct new product packages to support submission in EEMEA countries including efficiency and optimization/ simplification strategies
* Leads New Product Launch discussions and planning for EEMEA countries.
Maintenance of Registered products
* For late introductions, inline extensions, ensures that needed support is provided to all ongoing maintenance activities until product is registered in EEMEA.
* Participate in planning of products variation as per E2E guidance.
Compliance:
* Support Implementing Prescribing Information within the correct timeframes for compliance.
* Ensures that all internal customers receive relevant information with regard to the registration status of the newly assigned products.
* Ensures that files and archives 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:
* Coordinate with labeling hub Lead to ensure high quality review and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents for new products.
* 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 in support for launch.
Cross-functional activities:
* Ensures adequate support to other functions to enable compliance in areas related to new launches, such as supply.
* Secures timely and adequate information and decision making with regard to new launches including escalation and risk mitigation for delays
* Takes part in subsidiary product and launch teams to provide RA input and strategy advice.
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.
Supports EEMEA Team:
* Sets up priorities, organizes, oversees and monitors new products ' activities, towards division's and country's objectives achievement in compliance with policies and standards.
* 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 RA/ PV/
labeling.
Skills / Qualification Required:
* Must be hold a B.Sc degree in pharmacy or other life sciences.
* A minimum of 10 years experience in a Registration Department, which should include dealing directly with regulatory, commercial, medical, compliance, 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) as well as PC use with regard to word-processing, spreadsheets, database application, and internet.
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 communities they care
for. We have an important portfolio and are growing it by investing in the
unmet needs of Women's Health, expanding access to leading biosimilars and
touching lives with a diverse and trusted portfolio of health solutions. Our
Vision is clear: A better and healthier every day for every woman.
Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for
employment opportunities. All CVs / resumes submitted by search firms to any
employee at our company without a valid written search agreement in place for
this position will be deemed the sole property of our company. No fee will be
paid in the event a candidate is hired by our company as a result of an agency
referral where no pre-existing agreement is in place. Where agency agreements
are in place, introductions are position specific. Please, no phone calls or
emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID: R512282