Manager, Regulatory Affairs

1 week ago

Cape Town, South Africa IAVI Full time

**Position Description**

**Job Title**:Manager/Senior Manager Regulatory Affairs
**Location**: South Africa / Kenya
**Reports to**: Executive Director, Regulatory Affairs
**Position Summary**:
**Key Responsibilities**:
**_
Regulatory affairs:_**
- In collaboration with senior department members, plan regulatory strategies to support the development of different products in the IAVI portfolio.
- Maintain up-to-date knowledge on local regulatory requirements and changes to regulatory procedures and ensure that changes are communicated throughout the regulatory and clinical teams.
- Keep abreast of changes to global regulations.
Compile SAHPRA Clinical Trial Applications with input from project team members.
- Organize the preparation of all other statutory regulatory submissions e.g. Ministry of Health; Biosafety Committees.
Review investigational product labels to ensure compliance with country regulation.
- Track and manage the on-time submission of routine regulatory submissions such as periodic progress reporting, ongoing stability results, updates to Investigators Brochures, and responses to agency requests.
- Assist with the development and maintenance of departmental policies, work instructions, Standard Operating Procedures, and templates used for regulatory submissions.
**_
Departmental and knowledge development activities:_**
- Provide support and back-up to senior departmental personnel as needed, such as attending meetings, assuming lead in study team meetings or ad-hoc meetings, generating and/or reviewing minutes, and following up on action items.
- Remain up to date on knowledge of ICH GCP, SAHPRA-, EMA, FDA and other African countries regulations, and other local/international regulatory guidelines and requirements. Arrange for training of staff as needed.
- Participate in training activities for new staff, as needed.
- Identify and lead process improvement efforts. Participate in SOP writing and revisions as requested.
- Provide status reports on metrics associated with deliverables.
- Perform other duties as assigned by the manager.
**Education and Work Experience**:

Minimum 5 years of experience in Regulatory Affairs with expertise and working knowledge of SAHPRA policies and procedures is required.
**Qualifications and Skills**:

- Experience working with African regulatory agencies is required.
- Excellent track record of preparation and submission of regulatory dossiers is required.
- Knowledge of GMP, GLP, GCP and /or quality assurance and regulatory affairs associated with biologics and vaccines is required.
- Experience with CTA procedures and policies is required.
- Technical/Scientific Writing and Document Formatting is required.
- Excellent organizational skills and time management skills are required.
- Ability to work collaboratively and proactively with staff and external partners at all levels are required.
- Excellent verbal and written communication skills, as well as presentation skills are required.
- Working Knowledge of Microsoft Office Applications (e.g. WORD, EXCEL, PowerPoint, Project) is required.
**Organizational Overview**:
**IAVI CORE VALUES**:

- Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
- Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
- Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
- Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference

Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide

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