REGULATORY AFFAIRS MANAGER - Immploy Medical Recruitment Agency, East Rand

  • East Rand
  • Salary: Market Related
  • Job Type: Permanent
  • Posted by Immploy Medical Recruitment Agency on Friday, March 15, 2019
  • Reference: BJA999
  • Apply before Tuesday, May 14, 2019 - 53 Days left

Vacancy Details

Employer: Immploy Medical Recruitment Agency

JOB TITLE

Regulatory Affairs Manager 

DEPARTMENT 

Regulatory Department 

REPORTING LINE MANAGER 

The Chief Executive Officer and the Responsible Pharmacist 


Candidate Requirements

JOB TITLE

Regulatory Affairs Manager 

DEPARTMENT 

Regulatory Department 

REPORTING LINE MANAGER 

The Chief Executive Officer and the Responsible Pharmacist 

1.   Overall objective of Job Function

 To proactively monitor, review, interpret, and translate all national regulatory requirements of the Medicines Regulatory Authority, to develop and implement strategies for earliest possible regulatory approvals to support business plans, to maintain a good standing with the local regulators and to effectively manage the regulatory department in line with the company expectations.

 2.   Minimum Qualification 

Bachelor of Pharmacy Degree

3.   Basic Competencies and minimum experience 

(Knowledge, Skills & Attributes) 

Knowledge: 

Computer literacy.

Must have a thorough understanding of the laws and regulations governing registration of medicines in the applicable territories. – SADC countries. 

Skills:

 Organisational and managerial skills; problem solving; analytical skills; service orientation; decision making skills; interpersonal skills; report writing skills

 Attributes:

 Attention to detail; initiative; confidentiality; customer focused; logical thinking; information seeking; sense of urgency

 4.   Experience:

 >5 years experience in Regulatory Affairs with at least 2 years of managerial experience.

 

Detailed description of job:

 (Duties & Responsibilities)

 Delivery of annual product submission plan 

·Compiling/overseeing submission of dossiers according to annual product submission 

plan to SAHPRA and regional Medicines Regulatory Authorities within SADC 

·Due diligence on prospective dossiers from India as well as other 3rd parties.

 Delivery of Future Registrations.

 ·Continuous liaison with SAHPRA to ensure new product registrations are received on

 time to satisfy the requirements of the business.

 ·Compile/oversee that recommendations are responded to timeously.

 Life Cycle Management 

·To ensure that necessary updates are made to the Registration Dossier according to 

latest requirements of the MRA, including conversion of dossiers to the ZA-CTD

 ·To ensure timely approval of post registration amendments to avoid out of stock

 ·To ensure that the MRA is informed of changes to the registration dossier.

 Printed Packaging Material Review 

·Review for compliance with the registered dossier and final approval before print

(APLSA and third parties).

 Marketing Material

·Provide regulatory support during concept design of all new marketing material.

·Ensure compliance of all marketing material with the Marketing Code Authority and

legislation.

 Quality Assurance / Compliance. 

·Overseeing the various activities performed by the QA pharmacist in the department.

 Overseeing compliance to batch documentation review, annual product reviews, trend

 analysis and overall quality risk management.

 ·Ensuring adherence to SAHPRA and GMP guidelines by all relevant personnel.

 

·SOP review and approval, creation of new SOPs as and when required. 

·Vendor inspection audits when required. 

·Overseeing the handling of technical product complaints and queries in accordance 

with the guidelines and requirements. 

·Providing  feedback  to  the  business  regarding  any  quality  issues  in  the  Quality

Management Review 

Training and support 

·Providing training and support to Regulatory Affairs Pharmacists and Assistants. 

·Training and implementation on new SAHPRA guidelines. 

·Training  to  sales  and  office  personnel  on  Pharmacovigilance  and  other  relevant

subjects when required. 

3rd party 

·Liaising with India on all regulatory and quality assurance activities. 

·Co-ordinating GMP/GCP inspections of parent company’s manufacturing facilities with

 inspectors from the various Regulatory Authorities. 

·Controlling correspondence with other pharmaceutical companies and pharmaceutical 

consultants with regards to regulatory activities. 

·Vendor inspection audits of distributors and laboratories.

·Finalising agreements with 3rd party contract laboratories.

·Customer relationship management with all 3rd parties mentioned above. 

Pharmacovigilance 

·Collection of adverse drug reactions and reporting it to the global Pharmacovigilance

 department. 

·Providing Pharmacovigilance training and documenting these training activities. 

·Provide global Pharmacovigilance with sales data and regulatory information, on request.

 ·Keep abreast with applicable South African laws, rules and regulations and keep global

 Pharmacovigilance informed of significant developments relating to Pharmacovigilance. 

·Ensuring ‘Dear Healthcare Professional’ letters are sent out in the event of urgent safety 

updates

 ·Overseeing  that  package  inserts  are  updated  to  reflect  the  latest  updated  safety 

information. 

Local Manufacturing technical responsibilities:

·Ensure the CMO remains GMP compliant and complies with all local legislation and 

requirements as per the product dossiers. 

·Ensure that all batch documentation is reviewed and releases are done appropriately 

to ensure that safe and quality products are released to the public. 

·To provide technical support to the CMO regarding any queries or concerns related to 

any of the company’s products. 

Management responsibilities 

·Managing a team of Regulatory Affairs Pharmacists and Regulatory Affairs Assistants.

 ·Ensuring compliance to departmental targets by the various personnel of the Regulatory

 Affairs Department.

 ·Planning and delegating of monthly targets to staff members 

Reports and budgets 

·Report submissions to the General Manager relating to regulatory activities of South Africa. 

·Responsible for all budgets relating to the department – monthly/quarterly/annual budgets 

for regulatory submissions to South Africa, as well as the general departmental budget. 

·Responsible for submitting fee requisitions to the Finance department for all costs relating 

to the department.

 The right candidate must be experienced, goal driven and must be able to work independently.

 

This position reports to: CEO & RESPONSIBLE PHARMACIST Apply before Tuesday, May 14, 2019 - 53 Days left Companies may expire jobs at their own discretion. If you have not received a response within two weeks, your application was most likely unsuccessful.
Hot Job 21 people have applied for this job. 495 people have viewed this job.

Similar Jobs

More Immploy Medical Recruitment Agency Jobs

About Immploy Medical Recruitment Agency

Immploy Medical Recruitment was founded in 2003 and has since become one of the leading medical recruitment agencies in South Africa. We provide first-rate healthcare professionals, locum and permanent, to government and private clients. With over 13 years in the industry, Immploy is known for providing the best and most trusted medical professionals. We are a strategic and tactical team who has mastered the process of procuring professional staff. Immploy recognises the need for a trusted employment brand that minimise the risk of disputes, thus going above and beyond their service scope. We have the tools you need to facilitate professional employee and employer relationships. The focus on strategic areas such as employment branding, candidate relationship management and social networking assists us in developing a partnership with clients and health professional staff; resulting in the best staffing solutions.