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/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

CRLB Core Lab

        

LOCATION:

Algeria > Algiers : Micro-Zone d'activité Hydra

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 50 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable