Senior Regulatory Affairs Pharmacist
Senior Regulatory Affairs Pharmacist
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Salary Not Disclosed
1 Vacancy
Job Description
Introduction
A global Pharmaceutical company is seeking aSenior Regulatory Affairs Pharmacist withorthodox experience.
Duties & Responsibilities
Regulatory Compliance:
Monitor and ensure compliance with regulatory guidelines and requirements. Stay updated with changes in regulations and assess the impact on the organizations products and processes and also provide guidance to internal stakeholders on compliance matters.
Labelling and Packaging:
Involved in the development and review of product labelling and packaging materials to ensure compliance with regulatory requirements. Ensure that the information provided is accurate clear and in line with regulatory guidelines.
Quality Assurance Support:
Collaborate with quality assurance teams to ensure that manufacturing processes and facilities comply with regulatory standards. May participate in audits and inspections to assess compliance and address any non-compliance issues.
Post-Marketing Activities:
Involved in post-marketing surveillance and pharmacovigilance activities. Monitor and report adverse events evaluate safety data and ensure that appropriate actions are taken to protect patient safety.
Regulatory Intelligence:
Stay updated with the latest regulatory developments guidelines and best practices. Be able to analyze the impact of regulatory changes on the organization and provide recommendations for addition to these responsibilities play a crucial role in strategic decision-making within pharmaceutical companies. Provide regulatory expertise and guidance to support product development registration and commercialization strategies and assess the regulatory landscape and advise on potential risks and opportunities associated with regulatory requirements. Overall ensures that pharmaceutical products meet regulatory requirements are safe and effective and are available to patients in a timely manner.
Desired Experience & Qualification
- Pharmacist degree & registered with the SAPC
- Minimum 8years experience as a Regulatory Pharmacist and exposure to Quality Assurance would be an advantage.
- Strictly currently working at a generic company for orthodox
- Medicine registration and CTD/eCTD training
- Regulatory experience and skill in the compilation portal navigation preparation submission and maintenance of dossiers and new drug applications.
- Proficiency in one of South African languages is essential.
- Excellent written and verbal communication skills.
- Ability to manage multiple and varied tasks with enthusiasm and prioritization of workload with attention to detail.
- Computer literate such as DocuBridge with good numeracy skills.
- A flexible attitude with respect to work assignments and new learning.
- Self-motivated with a willingness to accept responsibility and challenges.
Package & Remuneration
Negotiable
Required Experience:
Senior IC
Employment Type
Full-Time
