Regulatory Affairs Specialist - Morocco page is loaded

Regulatory Affairs Specialist - Morocco

locationsMAR - Casablanca - Zerktouni time typeFull time posted onPosted Today job requisition idR524390 Job Description

Purpose of the role

In the role of Regulatory Affairs (RA) Specialist you will be responsible for fulfilling all regulatory requirements for your assigned project/products. You will collaborate with colleagues to ensure compliance with local laws and regulations. You will ensure timely submission together and compliant implementation related our Life Cycle Management activities of a large portfolio of products in the region. In this role you actively engage with our business partner in the region to implement the changes for the French west African countries. You will report directly to the PV (Pharmacovigilance) and RA Cluster Lead in French West Africa.

Responsibilities

Responsible for execution of local RA processes and activities in alignment with our systems and their associated Quality Management System, following departmental SOPs, company Policies and Procedures and country legislation

Assisting in development of product registration plans & strategies and working cross-functionally to review & communicate the registration strategy with management oversight;

Assisting in timely preparation and maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations and global standards;

Filing, storing and archiving regulatory data and documentation in accordance with department and company policies and local requirements;

Acting in full compliance with global and local SOPs and reporting any deviations or compliance concerns immediately and assisting in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues;

Translation of variations to local product labeling and initiate and approve artwork change

Required Education, Experience, and Skills

Bachelor’s or master’s degree in health (sciences), life sciences, medical sciences or another relevant field of study. Pharmacist or scientific degree.

English & French;

2-4 years practical experience in regulatory affairs /

- strong organizational skills;

Preferred Education, Experience, and Skills

Knowledge of Regulatory affairs environment in French West Africa countries. ·

Secondary Job Description

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.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at [اضغط هنا لمشاهدة البريد اﻹلكتروني] .

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.

Annualized Salary Range

Annualized Salary Range (Global)

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1