Regulatory Affairs Pharmacist at Johnson & Johnson

Summary

To effectively complete all required Regulatory tasks relating to product registrations and dossier lifecycle maintenance for products the local operating company (LOC) has regulatory responsibility and to ensure these tasks are performed in line with the local, regional legislation and Global Regulatory Affairs (GRA) EMEA/local strategy and directives. Countries covered include South Africa and Sub-Sahara Africa countries.

The main duties and responsibilities of the position are:

Applications for registration

• New regulatory submissions (NCE; Line extensions, etc.)
• Clinical submissions (new indications)
• Other: responding to resolutions (clinical/pharmaceutical)
• Regulatory Renewals (as applicable)
• Compiling and submitting applications for registrations (human products), in the eCTD/CTD (eSubmission) format, to the 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.
• 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 stakeholder notification of Registration approvals/product discontinuations.
• Collaborating with marketing (local CVT) to ensure product launch readiness and advising them of any developments thus enabling the CVT to optimize the strategy

Regulatory Compliance

• Type I/II variations
• Conversion to eCTD/eSubmission format
• Other (respond to HA letters, QA queries, exemption requests and renewals)
• Development and Maintenance of Labeling Documents in line with local regulatory (legislative) requirements and Global Regulatory Affairs (GRA).
• Maintenance of the regulatory dossiers post-registration in terms of pharm-chem (CMC) and other required variations.
• Notifying GRA of submission, interim Health Authority communication and approval dates as well as maintaining the local Regulatory Database and Global electronic platforms.
• Coordinating the approval and superseding of regulatory documents in response to Regulatory Affairs authority letters/approvals.
• Submission of exemption requests to HA (labeling, once off batch, post-importation testing etc.)

Regulatory Compliance (Safety)

• Safety reporting
• HCC compliance
• Inspection readiness
• Implementation of safety amendments requested by the local Health Authorities and liaising with GRA on such issues.
• Coordinating and submitting notifications and/or responses to the Health Authority following a request for additional safety information in line with local/GRA procedures.
• Receipt, response, tracking of HA queries including Dear Healthcare Professional letters.
• Maintenance of all related regulatory databases and electronic (tracking) platforms both local and regional.
• Ensuring safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors.
• Ensuring HCC and legal requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors
• Ensuring inspection readiness with respect to personal training compliance, and availability of a recent CV and individualized Job Description

Other Regulatory Activities

• Advertising (promotional) review and approval
• Printed components 
• initiation (R4AW), proof reading & final approval of all product-related printed components
• Review & regulatory approval of allocated promotional & training material within the allocated 24-hour turn-around time.
• Ensure all promotional and educational material is compliant with the Regulatory dossier (approved label), relevant Acts, Code of Marketing Practice; and GRA requirements and to confer with Medical Affairs/Marketing in this regard.
• Regulatory support to product managers in all matters pertaining to Regulatory.
• The local initiation (R4AW) and final approval of all printed components artworks (& text changes) for products the LOC has Regulatory responsibility.

Other features:

• Team collaboration and discussions about new guidelines, SOP's, sharing learning experiences and best practices
• Internal pre-submission quality reviews are completed for other RA experts before submission

Qualifications

We’d love to hear from YOU, if you have:

• B. Pharm. or Dip Pharm qualification.
• Registration with the South African Pharmacy Council
• Computer Literacy
• Excellent written and verbal communication skills
• Strong communication skills with key customers both internal and external (e.g. Global Regulatory Affairs, Marketing and MCC)
• Meticulous, accurate and a high level of attention to detail
• Ability to work independently in a highly pressurized environment.
• Self-starter, ability to multi-task and prioritize.

Core competencies required for this role:

• Knowledge of legislative requirements (Guidelines, The Medicines Act and Regulations).
• Knowledge of Foreign Registration Requirement (viz. Africa)
• Understanding of the Code of Marketing Practice
• Knowledge of international requirements.
• Understanding of departmental and company SOP’s.
• Proficient in Lotus Notes.
• Analytical and detail orientated.
• Planning and organization
• Teamwork and co-operation