Regulatory Affairs Specialist

Business & Product Management
Algeria 🇩🇿
October 2, 2023

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Job Description

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Job Description

OBJECTIVES: 

  • 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.

ACCOUNTABILITIES: 

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

LICENSES/CERTIFICATIONS:

  •  Pharmacy graduate.
  • Extensive experience in the pharmaceutical industry (4 years) in regulatory affairs or drug development.

Empowering Our People to Shine

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Takeda is committed to providing a safe and healthy working environment and to having a workforce that is as diverse as the patients we serve and the communities where we’re based. To achieve that inclusivity, we embrace and celebrate our differences, respecting and valuing each other regardless of race, color, sex, age, national origin, religion, gender identity, sexual orientation, disability or physical appearance. 

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LocationsAlgeriaWorker TypeEmployeeWorker Sub-TypeFixed Term (Fixed Term)Time TypeFull time

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