Manager, Regulatory Affairs

4 months ago

Cape Town, South Africa IAVI Full time

**Position Description**

**Job Title**: Manager, Regulatory Affairs
**Location**: Cape Town, South Africa; South Africa - Remote; OR Nairobi, Kenya
**Reports to**: Senior Manager, Regulatory Affairs

**Position Summary**

Are you experienced in Regulatory Affairs, and eager to help translate science into global health solutions?

**Key Responsibilities**:

- Plan regulatory strategies in collaboration with department leadership 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, ensuring that changes are communicated throughout the regulatory and clinical teams.
- Organize the preparation of regulatory submissions including meeting briefing packages, CTAs, and ongoing communications to regulatory agencies as required.
- Partner with project team members and clinical trial sites to write, compile, review and submit documents.
- Review investigational product labels to ensure compliance with country regulation.
- Track and manage the timely submission of routine regulatory submissions such as periodic progress reporting, ongoing stability results, updates to Investigators Brochures, and responses to agency requests.
- Contribute to departmental activities such as SOP and work instruction development and tracking and trending regulatory submission compliance.
- Perform other tasks as assigned by the manager

**E**ducation and Work Experience**
- Bachelor’s degree or equivalent in biological sciences, pharmaceuticals, or a relevant field is required; An advanced degree is desirable.
- Minimum of 5 years of experience in Regulatory Affairs with expertise and working knowledge of SAHPRA policies and procedures.
- Experience with the preparation and submission of regulatory dossiers is required.
- Experience working with African regulatory agencies is required.

**Qualifications and Skills**:

- Excellent organizational skills are required.
- Knowledge of and experience with 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.
- Ability to travel up to 20% of the time is 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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