Regulatory Affairs Specialist応募後で応募 求人ID R0098498 掲載日 06/08/2023 Location:Algiers, Algeria
- Responsible to execute optimal regulatory strategies aimed to deliver product approvals and/or life cycle management in accordance with the regulatory objectives of the local business to enable ultimate strategy and faster access to innovative medicines in Algeria.
- 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 local authorities prior implementation for all promotional & non promotional activities.
80% core operating activities:
- Ensure compliance of Algeria RA activities with local and pharma regulation (promotional and non-promotional activities related to country in scope)
- Executes preparation, submission as well approvals for Algeria regulatory submissions, including content / structure definition, preparation / review / collection of components, samples ordering and submission, and submission review. Acts as contact with Health Authorities for all RA activities in Algeria.
- Collaborate with Global Regulatory Affairs for required documents for preparation of regulatory dossiers
- Ensure complete ownership of “Product life cycle maintenance”- (Includes Registration, Renewals, Change Control, Variation filing, labeling compliance, tender support for all RA documents required ) & timely execution of all projects.
- Provide assessment of the impact of new and changing regulations/requirements in applicable in Algeria .
- Prepare (as needed) and review key application components and meeting materials and chair/attend 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.
- Interact with distributors/ PCH in Algeria; service providers and regulatory agencies to resolve related review questions
- Review and ensure timely approval of promotional and non-promotional material in Algeria and secure MOH approval where needed
- Ensure labelling 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
- Provide guidance/advice on international regulatory environments, provide assessment of the impact of new and changing regulations/requirements and ensure RA intelligence
- 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 product regulatory assessment to be done for each product respective changes and/or variations as per local applicable health authorities’ regulations and relevant Takeda standards in the respective Takeda system
- Cross functional effective collaboration with Algeria Cross functional team, General manager to ensure aligned RA strategy execution aligned with business need and support country growth and strategy implementation
10% additional responsibilities:
- Support the RA Manager & RA Head the UMEA and GEM RA team on specific projects as requested.
- Support Algeria country manager when needed when it come to strategic project and RA support needed
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- 4 years of total experience
- 3 years of extensive & solid d Regulatory affairs experience in Algeria medium to large size reputable organization/s for pharmaceutical products,
·In-depth understanding of regulation in Algeria
Personal Characteristics & behaviors
- Strategic thinker, innovative, able to drive multiple simultaneous initiatives, able to work under pressure
- Must be able to work in a fast-paced environment with demonstrated ability to deal with competing tasks and demands.
- Excellent leadership, managerial, interpersonal and relationship building skills
- Excellent verbal and written communication skills
- Goal oriented, focused, energetic, and enthusiastic
- IT savvy and process orientation
- Pharmacy graduate.
- Extensive experience in the pharmaceutical industry (4 years) in regulatory affairs or drug development.
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