Regulatory Affairs Expert GPH Small molecules, Africa LOCs
Reporting to: Cluster Reg HEAD TBD (ZA or NE or MOTUWA)
Preferred Locations: could be located any one of the following local Operating Companies Morocco Casablanca, South Africa, Ghana, Kenya, Nigeria
Travel requirements: 10%
Overall purpose of job:
Dedicated to the Global Public Heath portfolio in African Countries. The regulatory affairs specialist has the responsibility for regulatory activities and plans, renewal registration, registration, variation changes, safety issues.
To perform all required product tasks, following the plan and updates from GPH, 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 GPH
Share all local RA competitive intelligence with cross? country relevance as well as to make sure EMEA GPH 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
Essential duties and responsibilities:
Registration of new product
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 African operations teams) to ensure product
launch readiness and advising them of any developments thus enabling the team 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 checklists for regulatory activities
Liaison and main contact between LOCs and international groups
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
Other features of the job:
Keeps overview of all GPH small molecule specific activities:
Monitoring implementation of procedures
Shaping of RA environment (together with EMEA)
Operational contact with MoH/Health authorities and Distributor, LTR etc.
Essential knowledge and skills:
Bachelors Degree? scientific/ pharmacist
Initial experience in Regulatory Affairs at LOC level
Masters degree in Regulatory Affairs is desirable
Knowledge & Abilities
Good knowledge of regulatory requirements across Africa
Knowledge, understanding and interpretation of legislation across Africa
RA legislation knowledge and experience
Good level in English and preferably French
Used to Ms Office Suite
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
Strong interpersonal skills to deal with sensitive and occasionally contentious issues.
Rigorous attention to details
Desire to work as part of an effective, cohesive group
Cross functional relation builder
Socially smart, influencer
Curious and interested in different cultures
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.