Location: Morocco, Casablanca
Contract: Full Time
Johnson & Johnson, Janssen branch has an immediate opening for Regulatory Affairs Specialist MAG & Ghana which will be based in Morocco.
Overall, Purpose of this Job:
Dedicated to the portfolio management in Ghana and supporting compliance activities of Maghreb. The regulatory affairs specialist has the responsibility for regulatory activities and plans, renewal registration, registration, variation changes, safety issues.
The responsibilities & the impact YOU will have:
- To perform all required product tasks, following the plan and updates, enabling optimal label implementation and maintenance, enabling local strategy optimization.
- Ensure that, where relevant local issues are identified as potentially impacting RA strategy, these are highlighted to commercial team and required internal stakeholders.
- Share all local RA competitive intelligence with cross‐ country relevance as well as to make sure Emerging Markets Regulatory Liaison/s gets all relevant competitive intelligence and its interpretation / impact to enable strategic decisions.
- Ensuring optimal compliance to local, regional and Janssen regulations, to minimize risk for the patient and Janssen business.
Registration of new products:
- Compiling and submitting applications for registrations (human products), line extensions and renewals in the CTD format, to the relevant Health Authority (HA).
- Liaising with GRA for all outstanding information and samples required for successful product submission.
- Responding to all Clinical; Pharmaceutical & Analytical recommendations from the HA.
- Payment of any HA related registration/application/variation & retention fee (when required or via the local partner).
- Notifying GRA of submission, interim HA communications and approval dates as well as maintaining the local Regulatory Database and Global electronic platforms (tracking systems).
- Internal notification of Registration approvals/product discontinuations (QA).
- Collaborating with marketing (local CVT) to ensure product launch readiness and advising them of any developments thus enabling the CVT to optimize the strategy.
Maintenance and follow‐up of marketed products:
- Execute regulatory plans and manage timelines to achieve the stated goals.
- Coordinate the preparation, review, submission and follow‐up of regulatory files that are properly formatted and in compliance with local regulations.
- Track and follow‐up with local marketing authorization holder/Distributor submission of regulatory files (including but not limited to: renewals, variations, response to questions) to local Health Authorities and ensure that filing and submission meet local requirements and company objectives.
- Distribute/share official notifications and HA information with internal stakeholders as applicable.
- Execute actions as per applicable check‐lists for regulatory activities.
Liaison and main contact between LOCs and international group:
- Assess the core dossier from Global Regulatory for completeness.
- Forward all relevant information/data from and in accordance with local marketing authorization holder /distributor.
- Keep EMEA Regulatory informed of regulatory status in LOCs and forward to them requests and relevant information from LOCs.
Maintain archiving and appropriate databases and systems:
- Ensure electronic and paper tracking of regulatory activities and Marketing authorizations lifecycle
- Ensure archiving of regulatory dossiers
- Populate and update appropriate J&J databases as per J&J processes.
- Update, maintain and use regulatory databases, tracking tables and information systems.
Daily business & product supply Support:
- Write SOPs in accordance with the applicable responsibilities scope.
- Coordinate preparation of responses to specific Health authorities’ requests and support, as appropriate, preparation of the relevant regulatory dossiers (e.g. Importation requests, NPP, clinical trials application, etc.).
- Review packaging material to ensure compliance with the Marketing Authorization and Follow‐up implementation with the Quality team.
- Provide regulatory support to all company functions upon request.
- Review, as per request, promotional material to ensure compliance with the marketing authorization. Where applicable (e.g. No local regulatory responsible), archive promotional material and maintain a formal list of valid material.
- Report Adverse Event & product quality complaints as per J&J Pharmacovigilance guidelines.
- Comply with local laws & HCBI guidelines, Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC).
- Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and, where applicable, appropriately managed when planning projects, developing materials, executing projects and contracting vendors.
- Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and, where applicable, complied when planning projects, developing materials, executing projects and contracting vendors.
- Ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description.
We’d love to hear from YOU, if you have:
- Bachelor’s Degree‐ scientific/ pharmacist.
- At least 2 years’ experience in Regulatory Affairs.
- Good knowledge of regulatory requirements, Morocco Health Authority regulations & guidelines.
- Good level in English.
- Used to Ms Office Suite.
- Product RA legislation knowledge.
- Knowledge, understanding and interpretation of legislation.
- Excellent communication and presentation skills, both verbal and written.
- Ability to manage multiple assignments.
- Anticipation and Planning Skills.
- Analytical / conceptual skills.
- Awareness and ability to understand the broader picture on compliance and launch time.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences
That is why we in Morocco are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
This is what awaits YOU at J&J:
- A dynamic and inspiring working environment.
- Many opportunities to work on challenging projects and assignments.
- Possibilities for further personal as well as professional development.
- Many employee benefits.
Johnson & Johnson Morocco S.A. (7255)