Regulatory Associate

Sanofi

Employer Active

Posted 8 hrs ago

Experience

1 - 7 Years

Job Location

Algeria - Algeria

Education

Bachelor of Pharmacy(Pharmacy)

Nationality

Any Nationality

Gender

Not Mentioned

Vacancy

1 Vacancy

Job Description

Roles & Responsibilities

Comp tences :

  • Confidentiality and responsibility.
  • Skills in negotiation, active listening and communication.
  • Organization and great precision in the documentation.
  • Knowledge of local pharmaceutical regulations.
  • Digital competence.
  • Ability to plan and implement actions to achieve objectives.

Training and job requirements:

  • Pharmacist/ Doctor of Pharmacy by training.
  • Experience in regulatory affairs or industrial affairs is desirable.

- Proficient in spoken and written French, English and Arabic.

- Permit B.

Desired Candidate Profile

- Pharmacist/ Doctor of Pharmacy by training.

- Experience in regulatory affairs or industrial affairs is desirable.

- Proficient in spoken and written French, English and Arabic.

- Permit B.

Company Industry

  • Pharma
  • Biotech
  • Clinical Research

Department / Functional Area

  • R&D
  • Research & Development

Keywords

  • Regulatory Associate

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Sanofi

Responsible for the maintenance and regulatory compliance of the product portfolio under his/her care.

Responsible for all regulatory activities related to products assigned to a specific Business and/or therapeutic class, of the subsidiary.

In alignment and by delegation from the Regulatory Head, and/or responsible pharmacist, he/she represents the products under his/her care to the local authorities.

Participate in the development of the subsidiary's regulatory strategy and provide regulatory expertise to local and global project and business teams, for products in development and/or marketed, in compliance with rules of compliance and ethics.

Ensure the validation of artworks at the local and global level, and monitor the implementation of variation labeling within pre-established deadlines.

Ensure the timely updating of regulatory databases for the portfolio for which he/she is responsible.

Verify and validate promotional materials with Marketing and Medical in accordance with global processes and local regulatory procedures.

Ensure the preparation and monitoring of systematic release files for batches of imported products.

Participate in the drafting and validation of procedures.

Monitor regulatory changes in the external environment, and ensure competitive intelligence by assessing the potential impact on the business.

Participate in the preparation of files related to calls for tenders, where applicable.

Read More

https://sanofi.wd3.myworkdayjobs.com/en-US/SanofiCareers/job/Alger/Regulatory-Associate_R2830429-1

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