Regulatory Affairs Lead

Takeda Pharmaceutical Company Limited

Employer Active

Posted 3 hrs ago

Experience

5 - 8 Years

Job Location

Algeria - Algeria

Education

Any Graduation()

Nationality

Any Nationality

Gender

Not Mentioned

Vacancy

1 Vacancy

Job Description

Roles & Responsibilities


Job Description

Join Our Team as a Regulatory Affairs Lead - Algeria & Tunisia (1-Year Fixed-Term Contract)

We are seeking a highly skilled and experienced Regulatory Affairs Lead to join our team in Algeria for a 1-year fixed-term contract. The successful candidate will be responsible for leading the Regulatory Affairs (RA) team in Algeria and managing regulatory activities in Tunisia.

This role involves developing and executing regulatory strategies, ensuring compliance with local regulations, and facilitating faster access to innovative medicines.

Key Responsibilities:

  • Leadership and Strategy

    • Lead the RA team in Algeria and be an integral part of the local leadership team.

    • Collaborate with the RA head at EAMEA and align with the GEM RA team to provide regulatory strategies.

    • Communicate effectively with local health authorities for all regulatory affairs and registration activities.

    • Participate in the local pharma working group ALPI in Algeria.

    • Review and consolidate budgets with RA EAMEA and align with GM Algeria & Tunisia.

  • Core Operating Activities

    • Ensure compliance of Algeria RA activities with local and pharma regulations.

    • Lead the preparation, submission, and negotiation of approvals for Algeria regulatory submissions.

    • Collaborate with Global Regulatory Affairs for required documents for regulatory dossiers.

    • Manage product lifecycle maintenance, including registration, renewals, and change control.

    • Provide assessment of the impact of new and changing regulations in Algeria.

    • Review and approve promotional and non-promotional materials, securing necessary approvals.

    • Ensure labeling compliance and timely submission of safety updates and reports.

    • Develop effective working relationships with business partners and service providers in Algeria.


Company Industry

  • Pharma
  • Biotech
  • Clinical Research

Department / Functional Area

  • Administration

Keywords

  • Regulatory Affairs Lead

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Takeda Pharmaceutical Company Limited

https://takeda.wd3.myworkdayjobs.com/en-US/External/job/Algeria/Regulatory-Affairs-Lead---Algeria---Tunisia--1-Year-Fixed-Term-Contract-_R0181473-1

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