Regulatory Affairs Manager - Pharmaceuticals

Nairobi City, Nairobi Salary Negotiable

Apply before Thursday, November 25, 2021, 35 Days left

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Job Summary

A leading Pharmaceutical manufacturing company seeks to recruit a highly motivated professional to fill the position of Regulatory Affairs Manager.

Qualification Level: Bachelor

Experience Level: Management level

Experience Length: 5 years

Job Description

The company fosters to provide quality products efficiently and effectively. We are committed to providing a safe and dynamic work environment. We encourage our team to be self-starters and allow them to demonstrate their abilities.



Job Purpose

To ensure the appropriate licensing, marketing and legal compliance of products in order to control the safety and efficacy of products, advise on and coordinate the approval and registration of products and play the role of a crucial link between the company and regulatory authorities.

Duties and Responsibilities.

- Contribute to the development of the business strategy, aligns the functional strategy to the business strategy to the business strategy and provides technical advisory role to the business.

- Ensure all the licenses’ necessary to allow manufacturing/importation/exportation and distribution of pharmaceutical products are in place.

- Ensure all the products manufactured/distributed locally or exported to other countries are duly registered/retained annually in compliance with the current requirements of National Medicines Regulatory Authority (NMRA’S) in the respective countries.

- Ensure new product registration dossiers as well as those dossiers necessary for various NMRAs’/NGO’s/Private or Public Hospitals for registration of a product are done on a timely basis following current guideline for each country targeted or format issued by NGO or private hospital.

- Respond to queries arising from evaluation of dossiers by any of the organization mentioned (NMRA’S/NGO/Private or Public Hospitals within a month.

- Participate in meetings within and outside Kenya pertaining to regulatory affairs including FKPM, FEAPM.

- Notify respective NMRA and other organizations on quality issues which may have been detected by QA or other organizations.

- Train RA staff regarding Regulatory Requirements, including updating them on current requirements e.g. on guidelines in dossier preparation.

- Participate in internal audits as well as facilitate External audits.

- Develop and manage budget for the department

- Prepare timely management reports and present to the management or technical committee.

- Release of FPP and signing of other documents such as COA’S during the absence of QA head. Inspire and foster team commitment, develop the ability of the team and manage performance to deliver exceptional level of organization objectives and goals.

- Any other duty as may be assigned by person in authority.


- Degree in Pharmacy or Degree in Chemistry or Analytical Chemistry.

- Professional Qualification: Registered by the Pharmacy and Poisons Board.

- Masters is an added advantage.

- Minimum of 4 years of experience in Regulatory Affairs Preferably from Pharmaceutical Company.

Apply before Thursday, November 25, 2021, 35 Days left

Companies may expire jobs at their own discretion.

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