Regulatory Affairs Manager (Critical Care)

Emporium Human Capital

South Africa
Permanent
Full-time

16 days ago

Lead the Regulatory team to provide superior Regulatory services to relevant departments within thePOSITION INFO:Regulatory Affairs Manager (Critical Care) POS24104Aeroton/ Crown minesR 900 000 per annumPURPOSE OF THE JOBLead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs. To ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.REQUIREMENTS:

Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
Minimum of 5 years’ experience in Regulatory Affairs, preferably in human medicines. Demonstrated experience across the product development, commercialization and maintenance lifecycle
Sound project management capabilities
Proven ability to consistently deliver to quality, time and cost standards
Professional people management experience

Key Job Outputs

Manage work streams for- and report 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- Establish regulatory priorities and allocate resources and workloads- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards

Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to

- Develop regulatory strategies and implementation plans for the preparation and submission of new products- Conduct dossier due diligence to ensure all data gaps are addressed- Prepare the registration applications for submission to the regulatory authorities- Work in collaboration with NBD to assess regulator’s submissions requirements

Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the

industry. * Internal training and mentoring

Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Manage activities such as internal audits or regulatory agency inspections
Ensure alignment of personal and company values

Closing Date: 12 April 2024To apply please send CVs to and use “POS24102” or “Regulatory Affairs Manager” as reference.Please note that only shortlisted candidates will be contacted.Similar jobs you might be interested in:Location: Crown Mines
Salary: R800k - 900k per year
Lead the regulatory team to provide superior regulatory services to relevant departments within the
1 day agoLocation: Crown Mines
Salary: R800k - 900k per year
Lead the regulatory team to provide superior regulatory services to relevant departments within the
10 days agoLocation: Crown Mines
Salary: R800k - 900k per year
Lead the regulatory team to provide superior regulatory services to relevant departments within the
11 days agoLocation: Crown Mines
Salary: R800k - 900k per year
Lead the regulatory team to provide superior regulatory services to relevant departments within the
16 days agoLocation: Crown Mines
Salary: R800k - 900k per year
Lead the regulatory team to provide superior regulatory services to relevant departments within the
16 days agoLocation: Crown Mines
Salary: R800k - 900k per year
Lead the regulatory team to provide superior regulatory services to relevant departments within the
16 days agoLocation: Midrand
Salary: R1.6m - 1.8m per year
Head of regulatory affairs holds ultimate responsibility for the RX DIVISION'S regulatory activities
1 day agoLocation: Johannesburg
Salary:
2 days agoLocation: Johannesburg
Salary: Basic neg plus Medical and Provident Fund.
Isando
2 days agoLocation: Johannesburg
Salary:
1 day agoJobseekersRecruiterGeneralÂ© Copyright 2024 Executive Placements. All Rights Reserved.Create an email alert for Regulatory Affairs Manager (Critical Care) jobsWhat:Where:Email:Create Email AlertYou can cancel at any time. We will not spam you. By giving us your email address your agree to our and You agree to receive job alert emails from executiveplacements.com and/or our sister site jobplacements.com.

ExecutivePlacements.com

Apply Now