Regulatory Affairs Lead

il y a 6 jours

Alger, Alger, Algérie Takeda Temps plein

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Job Description:
Join Our Team as a Regulatory Affairs Lead - Algeria & Tunisia:
We are seeking a highly skilled and experienced Regulatory Affairs Lead to join our team in Algeria. 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.

Additional Responsibilities:

  • Support the RA Head EAMEA and GEM RA team on specific projects.
  • Provide strategic project and RA support to the Algeria and Tunisia country managers as needed.

Qualifications:

  • Education:
    Pharmacy graduate.
  • Experience:
    5-8 years of experience in regulatory affairs, with at least 5 years in a medium to large pharmaceutical organization in Algeria.
  • Skills:
    Strategic thinker, innovative, excellent leadership and communication skills, IT savvy, and process-oriented.

If you're ready to make a difference and take your career to the next level, apply now to become a key player in our Regulatory Affairs team

Locations:
Algeria

Worker Type:
Employee

Worker Sub-Type:
Regular

Time Type:
Full time

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