Regulatory Affairs Associate

Lagos - Nigeria

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

The Regulatory Affairs Associate supports the registration and lifecycle management of drug products across Anglophone West Africa to ensure timely patient access. This includes but not limited to timely submission consistent tracking communication and follow-ups with the Health Authority escalating and supporting resolution of any related issues securing relevant approvals (where there are no objections by the HA).

The role requires accurate and uptodate maintenance of all regulatory with regulatory-relevant data up to 95% compliance e.g. DRAGON and proper archiving of related records.

Ensures that compliance activities are executed in an accurate and timely manner including but not limited to submission of safety labelling changes safety communications audit preparation performance management tracking of quality assessments timely communication and resolution of compliance-related issues.

Implementation of Regulatory Affairs processes and quality standards according to governing SOPs and policies regularly track and provide updates on changes to regulatory guidance.

Support the RA Team in labelling management including tracking and submission of labelling changes and related activities for all Novartis products.

Maintaining open communication with internal stakeholders including Regulatory Affairs Teams Supply Chain CMC Labelling NTO and others as required and regularly provide feedback.

Develop and maintain good working relationships with the Health Authority.

Job Description

Major Accountabilities

Regulatory Submissions & Product Lifecycle Management

Prepare local dossiers and submit drug registration applications in a timely manner maintain regular communication with HA during evaluation phase to support favourable approval outcomes.

Support lifecycle maintenance activities including renewals and postapproval changes ensuring on-time submissions.

Maintain regulatory databases with accurate and up-to-date product information.

Health Authority Engagement

Liaise with the Health Authority on submitted applications provide timely feedback and follow-up for approvals.

Build and maintain strong working relationships with Health Authority officials.

Compliance & Quality Activities

Ensure compliance to global and local KPIs

Ensure timely handling of non-compliance issues and urgently escalate compliance issues through appropriate channels and provide necessary support for resolution.

Support audit readiness and compliance assessments.

Contribute to data consistency and quality control reviews including comparative assessments of relevant SOPs and other processed/documents as required.

Document and Database Management

Maintain accurate technical and non-technical documentation change system.

Maintain DRAGON and other relevant databases with up to date and accurate product

information under the supervision of the RA Managers.

Support data consistency management and CCEx activities.

Labelling Management

Support submission and tracking of labelling updates.

Contribute to labelling improvement initiatives and regulatory guideline reviews.

Support maintenance countryspecific regulatory presentations for products registered in Anglophone West Africa.

Timely escalation of issues related to product labelling and support in resolution.

Regulatory Intelligence

- Conduct consistent periodic regulatory guideline/policy reviews and communicate outcome of the reviews including the impact of identified changes.

- Communicate and emerging regulatory changes in a timely manner such as changes to Health Authority processes

Stakeholder Engagement & Internal Collaboration

Maintain open communication with internal stakeholders including Supply Chain CMC Labelling NTO other RA teams and other relevant parties.

Ensure distributors receive necessary documentation to support compliant importation.

Other Responsibilities

Provide support to assigned Regulatory Affairs projects and tasks and complete delegated tasks.

Appropriate communication of identified issues related to compliance and regulatory

intelligence affecting lifecycle management and any other issues deemed relevant.

Key Performance Indicators

Timely registration of new drug products and re-registration of approved products

Timely submission of post-approval changes (variations) and follow up with the Health Authority for approval.

Ensure compliance with relevant Health authority guidelines and regulations

Address issues related to compliance with urgency as appropriate

Accurate monitoring and maintenance of relevant regulatory information management system(e.g. DRAGON NRV Production Transfer Tool)

Achieve 95% Regulatory compliance deliverables (compliance with relevant databases trainings and any such deliverable)

Education: B. Pharm

Languages: Fluent in English (mandatory)

Experiences: Minimum 1-2 years RA experience

Good understanding of CTD dossier format

Good understanding of the regulatory landscape in Nigeria/Anglophone West Africa

Detail-oriented and organized

Good communication negotiation and inter-personal skills.

Skills Desired

Analytical Skill Clinical Trials Collaboration Detail-Oriented Lifesciences Project Planning Regulatory Compliance

Required Experience:

Job Description SummaryThe Regulatory Affairs Associate supports the registration and lifecycle management of drug products across Anglophone West Africa to ensure timely patient access. This includes but not limited to timely submission consistent tracking communication and follow-ups with the Hea...