Job Description

A global generic pharmaceutical company is seeking an RA Manager and RP.
As a Regulatory Affairs Manager, you will play a crucial role in ensuring compliance with regulatory standards in the industry. Your responsibilities will include developing and implementing regulatory strategies, collaborating with cross-functional teams, and ensuring that products and processes meet all relevant regulatory guidelines. This role requires strong attention to detail, exceptional communication skills, and a deep understanding of regulatory processes and requirements.
Compliance Management

• Comply with all provisions of the Medicine and Related Act 101 of 1965, Pharmacy Act and SAHPRA guidelines, ensure the necessary licenses, certifications, and permits are monitored and processed.
• Ensure that the organisation adheres to all relevant regulations pertaining to its products and operation.
• Stay updated on changes in regulations, assessing their impact on the business and communicating relevant changes to the Company.
• Oversee regulatory compliance activities including artwork, labeling, promotional materials, etc.
• Maintain regulatory files and records in compliance with internal policies and external requirements.

Risk Assessment

• Identify and assess regulatory risks associated with product development and market entry, developing strategies to mitigate these risks.

Communication with Regulatory Authorities

• Liaise with regulatory authorities to clarify requirements, fast track submissions, and address queries timeously.

Internal Audits

• Conduct internal regulatory audits to ensure compliance and implement corrective actions for any identified issues.
• Assume the lead role in all external audits and inspections and provide regulatory support during quality system and compliance reviews.

Documentation and Submissions

• Prepare and submit regulatory documents to relevant authorities to ensure the organisation remains compliant.
• Ensure timely regulatory submissions to support product launches, changes, and renewals.

Cross-Department Collaboration

• Work closely with various departments, including supply chain, marketing, research and development (Head Office) to guide product development from registration to market launch.
• Provide regulatory guidance to cross-functional teams including supply chain, marketing and sales.

Training and Education

• Conduct training programs for employees on regulatory changes and compliance importance, ensuring that all staff are informed about relevant regulations.

Team Management

• Manage team effectively to ensure project timelines are adhered to.

Core Competencies
Analytical Skills

• Strong ability to analyse complex regulations and assess implications for the organisation

Project Management

• Excellent project management skills to oversee multiple regulatory submissions and ensure timely compliance

Attention to Detail

• Exceptional attention to detail to ensure accuracy in documentation and compliance with regulatory standards

Leadership & Management

• Strategic vision & planning, team leadership & development, cross-functional collaboration

Communication & interpersonal skills

• Problem-solving & analytical skills, continuous learning & adaptability, ethical conduct

Requirements:

• Completed B. Pharm Degree and registration with South African Pharmacy Council
• A minimum of 8 years of pharmaceutical regulatory experience is a prerequisite with excellent knowledge and understanding of the current pharmaceutical industry
• Minimum of 5 years in people/team leadership is required
• Proven track record of successfully developing and executing regulatory strategies and obtaining timeous regulatory approvals for products

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.

Skills Required