Regulatory Affairs Manager North Africa
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
MAIN PURPOSE OF THE ROLE
Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function.
First level manager of a work team that may comprise professionals technical and/or administrative staff.
Typically without budget or hire/fire authority.
Focuses on mentoring coaching and coordination.
MAIN RESPONSIBILITIES
As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function supervises professionals in directing development of
product registration submission progress reports supplements amendments or periodic experience reports.
Interacts with regulatory agency to expedite approval of pending registration.
Serves as regulatory liaison throughout product lifecycle.
Participates in some of the following: product plan development and implementation regulatory strategy risk management
chemistry manufacturing control (CMC).
Ensures timely approval of new drugs biologics or medical devices and continued approval of marketed products.
Serves as regulatory representative to marketing research teams and regulatory agencies.
Advises development and/or marketing teams on manufacturing changes line extensions technical labeling appropriate
regulations and interpretations.
QUALIFICATIONS
Education
Education Level Major/Field of Study or Equivalent
Associates Degree ( 13 years)
Experience/Background
Experience Experience Details
Minimum 4 years
Licenses and Certifications
Language Proficiency
Language Proficiency
Note: This job description is not to be considered an exhaustive statement of duties responsibilities or requirements and does
not limit the assignment of additional duties for this role.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
CRLB Core Lab
LOCATION:
Algeria > Algiers : Micro-Zone dactivité Hydra
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 50 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
