Johnson & Johnson Family of Companies Vacancies 2022 in Johannesburg

Johnson & Johnson Family of Companies Job Vacancies 2022 notification out for Regulatory Affairs Pharmacist Jobs. Apply for Johnson & Johnson Family of Companies Jobs in Johannesburg. Check Latest Johnson & Johnson Family of Companies Government Jobs in Gauteng. How to Apply for Johnson & Johnson Family of Companies Vacancies at Official Johnson & Johnson Family of Companies Careers Portal. Find out here Upcoming South African Jobs Careers24 News at www.jnjconsumer.co.za.


Johnson & Johnson Family of Companies Vacancies 2022 Apply for Regulatory Affairs Pharmacist Jobs in Johannesburg

Johnson & Johnson Family of Companies has released a Regulatory Affairs Pharmacist job notification at www.jnjconsumer.co.za Careers website. Johnson & Johnson Family of Companies has displayed vacant seats for the post of Regulatory Affairs Pharmacist vacancies. Candidates satisfying the desired eligibility conditions as mentioned in the Johnson & Johnson Family of Companies official notification can submit their application in the prescribed format on before last date with the help of details given below-
NOTE:- Candidates are suggested to read the original Johnson & Johnson Family of Companies job notification before applying for desired post.

Name of Available Job Post ⇒ Regulatory Affairs Pharmacist
Name of Vacancies ⇒ Johnson & Johnson Family of Companies Vacancies 2022
Job Location ⇒ Jobs in Johannesburg
Salary ⇒ R 1,020,006.00 Yearly
Last Date ⇒ Untill Fill

Johnson & Johnson Family of Companies Job Description

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

Apply Now


Johnson & Johnson Family of Companies Vacancies 2022 Apply for Healthcare Compliance Specialist Jobs in Johannesburg

Johnson & Johnson Family of Companies has released a Healthcare Compliance Specialist job notification at www.jnjconsumer.co.za Careers website. Johnson & Johnson Family of Companies has displayed vacant seats for the post of Healthcare Compliance Specialist vacancies. Candidates satisfying the desired eligibility conditions as mentioned in the Johnson & Johnson Family of Companies official notification can submit their application in the prescribed format on before last date with the help of details given below-
NOTE:- Candidates are suggested to read the original Johnson & Johnson Family of Companies job notification before applying for desired post.

Name of Available Job Post ⇒ Healthcare Compliance Specialist
Name of Vacancies ⇒ Johnson & Johnson Family of Companies Vacancies 2022
Job Location ⇒ Jobs in Johannesburg
Salary ⇒ R 1,350,003.00 Yearly
Last Date ⇒ Untill Fill

Johnson & Johnson Family of Companies Job Description

Job purpose

  • Health Care Compliance Specialist supports HCC program transactions for the Consumer and Medical Devices organization. He / she supports planning, training, assessments, testing, monitoring and other HCC functions required. This person is also responsible for maintaining existing programs and implementing activities related to Management Action Plans.
  • This role is first level support for Foreign Corrupt Practices Act and other J&J audits related to HCC program and related documentation.
  • Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to achieve required results.

The main duties and responsibilities of the position are:

  • Reconciliation of all HCC related activities by J&J Consumer and Medical Device South Africa, which includes working closely with the business until HCCLIFE activities are reconciled and closed, and ensuring that actual spend is in line with approval requirements.
  • Remediate audit findings and implementation of the related Management Action Plans.
  • Works closely with HCC Officer and Manager and maintain visibility to our local trade associations (Marketing Code Authority and SAMED).
  • Collaborate effectively with sales and marketing leadership, and any other stakeholders as required.
  • Approves all HCC related invoices to enable finance team to process the payments, which includes ensuring that all invoices contain the minimum required information as per auditor requirements.
  • Working closely with internal and external auditors and providing them with the required reports and data required for audit purposes.
  • Providing reports and data to monitoring team and also assisting them whenever required with their queries.
  • Checking the quality of HCC relevant event documentation is in line with HCC guidelines prior to HCC approval.
  • Supporting business with any HCCLIFE related queries on a day to basis.
  • Providing HCCLIFE data to Business, Auditors and monitoring/testing teams.
  • Provide robust metrics to business leaders as required, which includes analysing of Third Party Intermediary Due Diligence requirements, Unplanned Deviations, Monitoring and Management Action Plans.
  • Provide training for the business on the HCC program, remediation and Due Diligence as required.
  • Support the Business with HCC related programs such as but not limited to HCCLIFE and EPIC.
  • Support communication to the Business on HCC related matters as required.
  • Assist in harmonization, preparation, updating and implementation of all HCC written policies and procedures on an ongoing basis.
  • Maintain employee certification and training attendance records.
  • Organize and support training / team meetings / other HCC meetings.
  • Maintain HCC Sharepoint site.
  • Support new hire orientation training and other required HCC training.
  • Support HCCO with any other ad hoc projects, as required.

This job descripton is not an exhaustive list of all the job holders’ responsibilities

Qualifications

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

  • BA / BS / advanced degree or equivalent is preferred
  • At least 2 years work experience
  • Legal and / or compliance program knowledge / experience an advantage
  • Proficiency in IT systems required
  • Excellent communication, presentation, and interpersonal skills with an ability to work with all levels of the organization. Must be detail orientated and meticulous in work activities.
  • Team player who can show initiative and recommend continuous improvement.
  • Proven track record in delivering results, self-starter, and ability to manage complexity is a must.
  • Industry related experience preferred: compliance, regulatory, legal or auditing.
  • Compliance experience in consumer, medical device or pharmaceutical industries is a plus.
  • Ability to manage conflicts in an open and constructive manner.
  • Strong analytical skills, strong influencing skills, ability to deal with complexity, strategic and tactical thinking.

Apply Now

Be the first to comment

Leave a Reply

Your email address will not be published.


*