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