SENIOR REGULATORY AFFAIRS PHARMACISTS

Jordan HR; Midrand; On-site; ZAR 200 000 - 300 000; Full time

Job summary

An established industry player is seeking a Senior Regulatory Affairs Pharmacist to enhance their regulatory team. This pivotal role involves managing a portfolio of products, ensuring compliance with regulatory standards, and liaising with various stakeholders. The ideal candidate will possess a strong background in regulatory affairs, particularly in human medicines, and demonstrate excellent project management skills. Join a dynamic environment where your expertise will contribute to the success of innovative pharmaceutical products. If you are passionate about regulatory affairs and thrive in a collaborative setting, this opportunity is perfect for you.

Qualifications

• 5+ years in Regulatory Affairs, preferably in human medicines.
• Experience with product development and regulatory compliance.

Responsibilities

• Manage product portfolios and external queries from regulatory bodies.
• Review submissions for compliance and accuracy.

Skills

Regulatory Affairs

Project Management

Good Manufacturing Practices (GMP)

Problem Solving

Customer Relationship Management

Education

Bachelor’s Degree in Pharmacy

Diploma in Pharmacy

Tools

CTD Software Builder

Microsoft Office

Job description

Pharmaceutical Client looking for a Senior Regulatory Affairs Pharmacist, to support the regulatory team to provide superior regulatory services to relevant departments within the company and with external partners and to control and manage a portfolio of product outputs.

POSITION INFO: Qualifications

Bachelor’s Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council.

Experience

• 5 years’ experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and devices for end-to-end regulatory activities.
• Demonstrable experience across the product development, commercialization and maintenance lifecycle.
• Sound project management capabilities.
• Proven ability to consistently deliver to quality, time and cost standards.
• Good Manufacturing Practices (GMP).
• Pharmaceutical production experience or exposure to supplement regulatory knowledge.

Core competencies

• Experience in use of CTD software builder and compilation of eCTD dossier applications.
• IT skills including Microsoft Office, ability to prioritise and work to tight deadlines.
• Systems and operations analysis, basic cost management skills, active learning and strategic thinking.
• Cross Functional skills: Ability to network, liaise and negotiate with others.
• Ability to set standards and objectives and monitor progress.
• Complex problem solving and decision-making skills, customer relationships, development of people.
• Must demonstrate responsibility, excellence and collaboration and align with company values.

Key Job Outputs

Manage work streams for- and report on the assigned portfolio of products:

• External product queries from the SAHPRA, other MRAs and third party stakeholders.
• Establish regulatory priorities and allocate resources and workloads.
• Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory.