Regulatory Affairs Associate (1 year fixed-term contract)

Takeda Pharmaceutical Company Limited

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Job Description

Objective/Purpose:

The Regulatory Affairs Associate is responsible for supporting the operational regulatory activities required for product approvals, maintenance, and lifecycle in compliance with regional local /global regulations. The role involves collaboration across cross-functional teams, regulatory authorities, and external stakeholders to ensure smooth execution of regulatory processes.

• Responsible for all communication with local health authorities for all regulatory Affairs & registration activities.

• The individual will execute all the regulatory activities related to registration requirements, renewals and products lifecycle maintenance for Algeria.

• Incumbent is expected to act in compliance with country policies and practices to reduce company's exposure to Regulatory risks.

• Secure needed approval from focal authorities prior implementation for all promotional & non-promotional activities.

Responsibilities:

• Prepare (as needed) and review key application components and meeting materials and chair/at tend meetings with regulatory agencies and other stakeholders.

• Ensure appropriate evaluation of local business and regulatory registration requirements for investigational and marketed products and prepare regulatory assessment reports as needed.

• Secure MOH approval where needed for promotional and non-promotional materials

• Ensure labeling compliance and timely submission of safety updates and reports as per set deadline.

• Ensure all RA Algeria archiving of RA and technical documents in a secured and comprehensive manner

• Ensure that all local product information used locally are up to date in the local regional database.

• Maintain compliance of LOC within internal systems and databases, and ensure accurate information is provided in a timely manner

• Develop effective working relationships with business partners cross functional team and service providers in Algeria including local weekly visits as needed.

• Support the RA regional and international teams on specific projects as requested

• Ensure effective cross functional collaboration and strong alignment with line manager RA Lead on all assigned operational RA activities

10% additional responsibilities:

Support the RA Lead & GEM RA Area Head on specific projects as requested.

Requirements:

• Pharmacy graduate.

• Knowledge of regulatory requirements specific to Algeria

• 1 year in regulatory affairs or equivalent roles in the pharmaceutical industry (ideally)

• Strong attention to detail to ensure compliance with health authority guidelines.

• Excellent communication and negotiation skills.

Role Profile

• Must be able to work in a fast-paced environment with demonstrated ability to deal with competing tasks and demands.

• Excellent interpersonal and relationship building skills

• Excellent verbal and written communication skills

• Ability to work effectively in a team environment.

• Goal oriented, focused, energetic, and enthusiastic

• IT savvy and process orientation