Regulatory Affairs Pharmacist Verfied

Salary Negotiable Not Specified more than 14 days ago 15-02-2018 9:34:48 PM
08-03-2018 9:34:48 PM

A leading global Generic Pharmaceutical company has a vacancy for a seasoned RA Pharmacist. This will be an excellent opportunity to excel in RA and grow with a reputable organisation!

POSITION  :   Regulatory Affairs Pharmacist

AREA          :   Eastern Suburbs

SALARY      :   R 700 000 CTC to R 750 000 CTC

 

MAIN PURPOSE OF THE ROLE:

To initiate and maintain portfolio registrations of new and existing product dossiers to ensure compliance to all respective legal requirements in order to avoid any business and legal ramifications.

 

SKILLS & QUALIFICATIONS:

  • Completed B.Pharm or equivalent
  •  MUST have a minimum 4 years’ experience in Regulatory Affairs.
  • MUST have xperience in both new product applications & maintenance of registered products.
  • Experience with Novel drug applications; including Biosimilars, Complementary and/or Medical Devices will be an advantage!!
  • Manufacturing/or quality experience in the pharmaceutical industry will be an advantage
  • All relevant Acts,legislation,regulations and guidelines that govern the Pharmaceutical Industry
  • Relevant requirements of the Responsible Pharmacistasoutlinedin the Medicines Act and the Pharmacy Act
  • Sense of urgency
  • Attention to detail
  • Leadership skills & team-working skills
  • Planning skills
  • Logical thinking
  • Communication skills(verbal and written)
  • Proactive solution orientated
  • Relationship building ability
  • Computer literacy(MSOffice)
  • Detailed technical knowledge of dossier requirements
  • Knowledgeof principles governing regulatory requirements such as ICH guidelines on stability,validation of various processes.

DUTIES & RESPONSIBILITIES:

1)   New Product Management

Submissions

  • Evaluate source dossier and complete gap analysis
  • Liaise with the Business Unit (BU) and New Business (NB) and confirm product requirements
  • Obtain additional data from Global affiliates
  • Compile according to the format required in South Africa
  • Submit dossiers to Medicines Control Council
  • Assess, coordinate data required and compile response to P&A queries
  • Assess and compile response to clinical queries
  • Monitor and follow up on responses submitted to MCC in line with business strategy
  • Communicate anticipated product registrations timeously to facilitate early preparation for launch

 Launches

  • Manage launch readiness for new products to ensure positive registration of the product, which intern leads to a successful launch in line with commercial priorities.
  • Assist with variation planning, so as to avoid any launch delays
  • Communicate any risks with Business Unit and Launch Management and work collaboratively in seeking solutions and/or alternatives
  • Proactive and strategic processing and application of regulatory initiatives to ensure successful launch and continued marketability of the products

2)   Post-Registration / Maintenance

  • Conversion of dossiers to CTD (update/change format)
  • Compile and submit variations/amendments for dossier to ensure compliance with current requirements and with current manufacturer/packer specifications and methods.
  • Ensure continued viability of all registered products through compliance to the respective regulatory and legal requirements and hence mitigating risk
  • Coordination of the receipt of variation data, compilation and submission of the variation of the registered product file, to the MCC, within the determined priorities
  • Track and follow up on the status of the variation within the anticipated timelines and communication status to relevant parties
  • Highlight potential stock risks and communicate with relevant parties accordingly
  • Pre-empt queries and address issues pro-actively prior to submission
  • Attend professional body (e.g. SAPRAA) and trade industry association (NAPM) meetings or other when necessary

3)   Artwork and Promotional Material

  • Collaborate with Business Unit at concept stage on promotional items and provide insight and recommendations in accordance with all applicable legislation
  • Review and approve all artwork/printed packaging and promotional material for all medicines and related products in compliance with all applicable legislation
  • Coordinate the approval process for all material and ensure timelines are adhered to.

4)   Customer Service

  • Address all internal and external queries
  • Build and sustain relationships with the Medicine Control
  • Council and Department of Health, where applicable
  • Work in close association with all internal departments and
  • Global affiliates
  • Align Business Unit and Company priorities with RA product portfolio.

 

Please note that if you have not received a response within 14 days of submitting your application that your application was unsuccessful. However, please keep a lookout on our website, for available positions which may be inline with your career aspirations.

 

Ref: JHB000193/S