Group Regulatory Affairs Manager

Recruitment Matters Africa Pvt Ltd

Job Location:

Nairobi - Kenya

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

We are seeking a strategic and detail oriented Group Regulatory Affairs Manager to lead our clients regulatory compliance efforts and prepare the organisation for the adoption and implementation of new technologies. This role reports directly to the Group CEO.

Salary and Benefits:

Negotiable

Responsbilities:

Keep up to date with national and international legislations guidelines and certification models
Watch the evolution of technology regulations potential market access authorizations and commercial - customer adoption
Collect collate and evaluate scientific and commercial data from a range of sources
Advise Research Production and Commercial on regulatory requirements
Provide strategic advice to senior management throughout the development of new technologies
Contribute and/or manage teams of colleagues involved with the development of new technologies
Review company practices and provide advice on changes to processes and systems
Ensure the roll out and monitoring of Technology Use agreements in line with contractual obligations from technology providers
Review marketing and communication material and ensure alignment with regulations and contractual obligations
Prepare Standard Operating Procedures (SOPs) for seed applied technology solutions and products in line with different certification processes.
Support country teams in preparing for external audits and stewardship audits
Prepare stewardship reviews and risk assessment processes for new technologies solutions and products
Prepare incident management response procedures (crisis management)
Support the organization in implementing stewardship SOPs
Ensure the companys SOPS are aligned with regulatory expectations/directives
Align the companys SOPs with contract obligations for production manufacturing warehousing and all aspects of the activity cycle
Review/update product labels to be aligned with contractual obligations
Training of internal stakeholders distributors and develop training material for customers on technology use and stewardship legal obligations
Develop Issues Management procedures as well as Adverse Effects reporting procedures

Key Skills:

Minimum 5 years experience in a Life Sciences discipline ideally Seed / Biotech / Crop Protection or Pharmaceutical Industry
Understand industry certification and stewardship policies/regulations
Good communication and interpersonal skills
Proven experience with regulatory submissions and product registrations
Excellent project management and leadership skills
Minimum 5 years of experience in regulatory affairs preferably in a regulated industry
Project Management skills

Qualifications:

Post graduate degree in a scientific discipline and/or business management
Strong knowledge of local and international regulatory frameworks (e.g. ICH ISO GxP GSG)

Salary and Benefits:

Negotiable

Responsbilities:

Keep up to date with national and international legislations guidelines and certification models
Watch the evolution of technology regulations potential market access authorizations and commercial - customer adoption
Collect collate and evaluate scientific and commercial data from a range of sources
Advise Research Production and Commercial on regulatory requirements
Provide strategic advice to senior management throughout the development of new technologies
Contribute and/or manage teams of colleagues involved with the development of new technologies
Review company practices and provide advice on changes to processes and systems
Ensure the roll out and monitoring of Technology Use agreements in line with contractual obligations from technology providers
Review marketing and communication material and ensure alignment with regulations and contractual obligations
Prepare Standard Operating Procedures (SOPs) for seed applied technology solutions and products in line with different certification processes.
Support country teams in preparing for external audits and stewardship audits
Prepare stewardship reviews and risk assessment processes for new technologies solutions and products
Prepare incident management response procedures (crisis management)
Support the organization in implementing stewardship SOPs
Ensure the companys SOPS are aligned with regulatory expectations/directives
Align the companys SOPs with contract obligations for production manufacturing warehousing and all aspects of the activity cycle
Review/update product labels to be aligned with contractual obligations
Training of internal stakeholders distributors and develop training material for customers on technology use and stewardship legal obligations
Develop Issues Management procedures as well as Adverse Effects reporting procedures

Key Skills:

Minimum 5 years experience in a Life Sciences discipline ideally Seed / Biotech / Crop Protection or Pharmaceutical Industry
Understand industry certification and stewardship policies/regulations
Good communication and interpersonal skills
Proven experience with regulatory submissions and product registrations
Excellent project management and leadership skills
Minimum 5 years of experience in regulatory affairs preferably in a regulated industry
Project Management skills

Qualifications:

Post graduate degree in a scientific discipline and/or business management
Strong knowledge of local and international regulatory frameworks (e.g. ICH ISO GxP GSG)