Job Description

A Leading Pharmaceutical Company has a vacancy for a Regulatory Affairs Pharmacist.Job Purpose:
Manage a Portfolio of Products, providing Regulatory strategy and support cross-functionally to achieve defined outputs on product development, commercialization and maintenance lifecycle. To ensure legal compliance with the relevant Medicine Regulatory Authorities. Ensure compliant and timely processing of regulatory submissions and commitments.Key Responsibilities:

• Manage work streams for- and report on the assigned portfolio
• Co-ordination, endorsement and submission of new product applications in South Africa and other applicable territories
• Co-ordination, endorsement and submission of amendments for currently marketed products
• Manage work streams for successful implementation of RA changes into market
• Internal training
• Assisting with internal product queries from relevant departments
• Assisting with external product queries from SAHPRA and third-party stakeholders
• Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders

Requirements:

• Bachelorxe2x80x99s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
• Minimum of 2 yearsxe2x80x99 experience in Regulatory Affairs, preferably in human medicines
• Demonstrable experience across the product development, commercialization and maintenance lifecycle
• Project management capabilities

Competencies:

• Attention to detail
• Knowledge of the Regulatory requirements for Pharmaceutical products in South Africa, knowledge of other markets is favourable
• Project management skills
• Ability to prioritise and work to tight deadlines
• Systems approach
• Cross-Functional skills: Ability to network, liaise and negotiate with others
• Problem-solving and decision-making skills
• IT skills
• Active learning
• Strategic thinking
• Ability to cope with a high degree of complexity and change
• Cross-Functional skills: Ability to network, liaise and negotiate with others
• Must demonstrate responsibility, excellence and collaboration and align with Company values

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com
Should you receive no feedback within 7 days, please accept your application as unsuccessful.

MNA Recruitment