Regulatory Affairs Expert - GPH Small Molecules, Africa LOCs at Johnson & Johnson

Ref. ID.: 00001H3Q
Locations: Ghana; Nigeria; South Africa; Morocco; Kenya
Category: Regulatory Affairs
Reporting to: Cluster Reg HEAD TBD (ZA or NE or MOTUWA   
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.

Key Accountabilities

• 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).

Compliance Responsibilities:

• 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
• Compliance
• Intelligence
• Shaping of RA environment (together with EMEA)
• Operational contact with MoH/Health authorities and Distributor, LTR etc.

Job Requirements
Essential Knowledge and Skills:

• Bachelor’s Degree‐ scientific/ pharmacist
• Initial experience in Regulatory Affairs at LOC level
• Master’s 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

Skills:

• 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.   

Personal Qualities:

• Fast learner
• Highly organized
• 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