Regulatory Affairs Associate (1 year fixed-term contract)
Takeda
Unknown, Unknown, Algérie ⵍⵣⵣⴰⵢⴻⵔ الجزائر
Full-Time
Competitive
OfficeAssociate
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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
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.