Alternating Regulatory Affairs - (M/F)

Duration from 6 months to 1 year (from October 2022)

AbbVie is a global, research-based biopharmaceutical company. Its mission: to provide its expertise, human resources and a unique approach to innovation to develop innovative therapies that respond to serious or chronic diseases in several therapeutic areas: immunology, oncology, ophthalmology, virology, neuroscience, in addition to the products and services of the Allergan Aesthetics portfolio. AbbVie also remains committed to historical areas such as anesthesia. The group employs more than 48,000 people in 70 countries.

For more information: www.abbvie.com - www.abbvie.fr.

We offer two work-study internships in Regulatory Affairs (RA).

 Their supervision and supervision of their activities will be carried out by an AR Pharmacist and a Senior AR Pharmacist.

Your Main Missions

Advertising

1. Verification of promotional and non-promotional material in accordance with enforceable references and the legislative and regulatory provisions in force.
2. Verification of the list of equipment made available to medical visitors.
3. Verification of Product and Competitor training materials.
4. Contributes to the preparation of the submission of promotional material to the ANSM within the deadlines set.
5. Contributes to the ranking of promotional and non-promotional material.
6. Contributes to the establishment of balance sheets related to the activity of the service.

Patients Support Programs

Verification of patient program materials.

Digital projects

1. Assistance in the development of regulatory recommendations for digital projects for Healthcare Professionals, patients and the general public.
2. Support for regulatory monitoring of digital projects and the  e-health environment.
3. Assistance in the critical/risk analysis of projects.

Main activities

Check in

1. Contributes to the local management (e.g. translations) of MAs under the European procedure (centralised and mutual recognition procedure) within the time limits set.
2. Contributes to the sustainability of all the documentation relating to the MA file and the MA more precisely by classifying the documentation according to the instructions defined by the service.

Packaging items

Establishes under the supervision of the Ar Pharmacist , the proofreading of packaging items in accordance with the regulations in force.

VIDAL Monographs

Establishes under the supervision of the AR Pharmacist , the proofreading of VIDAL monographs with regard to official texts.

Procedures

Contributes to the updating of procedures or any investigation necessary for their optimization.

Regulatory monitoring

Helps the service to establish a regulatory watch and to inform the latter of any changes related to french and European pharmaceutical regulations.

Basic:

• Profile

•  5th or 6th year of Pharmacy in Master in Regulatory Affairs.
• Good level of English.
• Knowledge of the company's products and competitors, as well as legal and regulatory requirements are a plus.
• A spirit of synthesis and ability to critically analyze.