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REGULATORY AFFAIRS MANAGER - 368763
Reference:
368763
Date Posted:
2021-03-07
Job Title:
REGULATORY AFFAIRS MANAGER
Industry:
Biological / Scientific / Pharmaceutical / Medical Research
Type:
Permanent
Wage / Salary:
R - Market Related - P/M (Per Month)
Location:
Johannesburg, Gauteng
Country:
South Africa
Closing Date:
2021-05-06
Job Description:
A leading pharmaceutical manufacturer and wholesaler, providing a dynamic range of products and services is seeking a Regulatory Affairs Manager who will support the regulatory team to provide superior regulatory services to relevant departments within the company and with external partners and principals, control and manage portfolio as well as team outputs. Ensure legal compliance with the relevant medicine regulatory authorities medicines and related substances control Act and South African Pharmacy Council ensuring timeous processing of regulatory applications
Duties & Responsibilities
Key Job Outputs:
Managing work streams and reporting on the assigned group of portfolios
Assisting with internal product queries from relevant departments
Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders
Establishing regulatory priorities and allocating resources and workloads
Reviewing regulatory agency submissions of materials to ensure timelines, accuracy, comprehensiveness or compliance with regulatory standards
Co-ordinating and submitting new product applications in South Africa and other applicable territories
Developing regulatory strategies and implementation plans for the preparation and submission of new products
Conducting dossier due diligence to ensure all data gaps are addressed
Preparing the registration applications for submission to the regulatory authorities
Working in collaboration with NBD to assess regulator’s submission requirements
Ensuring the maintenance and updating existing registrations in accordance with the relevant legislation, regulations and guidelines
Maintaining current knowledge of relevant acts, regulations and guidelines pertaining to the pharmaceutical industry
Managing internal training and mentoring
Establishing and maintaining effective relationships with regulatory authorities, internal and external stakeholders
Formulating or implementing regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced
Managing activities such as internal audits or regulatory agency inspections
Ensuring alignment of personal and company values
Core Competencies:
IT and leadership skills
Management of personnel resources
Ability to prioritise and work to tight deadlines
Systems and operations analysis
Basic cost management skills
Active learning and strategic thinking
Ability to cope with a high degree of complexity and change
Ability to network, liaise and negotiate with others
Ability to set standards and objectives and monitor progress
Complex problem solving and decision-making skills
Developing and maintaining good customer relationships
Development of people
Demonstrate responsibility, excellence and collaboration and align with company values
Desired Experience & Qualification
Qualifications:
Bachelor’s degree in Pharmacy and registration with the South African Pharmacy Council
Experience:
Minimum of 5 years’ experience in Regulatory Affairs, preferably in human medicines
Demonstrable experience across the product development, commercialisation and maintenance lifecycle
Sound project management capabilities
Proven ability to consistently deliver to quality, time and cost standards
Experience in use of CTD software builder and compilation of eCTD application will be an advantage
Package & Remuneration
Salary: Market related
