Hamilton Lloyd and Associates – Our client is a global leader in innovative pharmaceuticals product with recent presence in Nigeria. As part of their expansion process in Nigeria, they have decided to start the search for a Regulatory Affairs Manager, Nigeria.
Job Title: Regulatory Affairs Manager
Location: Lagos
Role Summary
- The registration of new drug products and the maintenance of registration of approved drug products in order to ensure viability of these products in the marketplace.Maintaining good relationship with KOL at the HA for enhancing registration of new products and renewal of registration of the approved products.
- Maintaining all necessary Company databases (e.g. DRAGON) to ensure regulatory compliance at all time. Maintaining open communication with the different stakeholders and regularly providing all required reports. Liaison between different stakeholders on regulatory matters.
Key Responsibilities
- To lead, develop and manage regulatory affairs team
- To lead the strategic planning and co-ordination of submission of drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve approval in line with planned registrations
- To ensure (through follow up) that documents for new registration and re-registration are got to ensure submission is achieved by due dates
- To ensure that submissions for license renewal are done in good time before license expiry so as to achieve approvals and to avoid Top line impact due to license expiry
- To ensure submissions for production transfers and pack size extension are made and approvals got by due dates
- To apply for and get approvals for pre-license promotion through named patient basis or orphan drugs
- To enhance and facilitate approval of new products and re-registration of already approved products as at when due
- Ensure DRAGON compliance for Country folder and Brand Safety Folders. To ensure timely submission and approval (when required) of variations and RMPs and ensure DRAGON is updated accordingly
- Review and approval of marketing promotional materials as NP4 member
- Renew Company premises license annually with Pharmacists’ Council of Nigeria (PCN) before 31st of January each year
- Develop and maintain good working relationships with other Company departments both locally and with Head Office and with health authority and industry bodies, such as the NIROPHARM. Provide valuable regulatory advice as necessary.
- Provide adequate training and guidance to all regulatory associates
- Support our distributors on regulatory issues
- To participate in pre-launch and in LRR preparation
Ethics and Compliance:
- Works within Ethics and Compliance policies and ensures those around him/her do the same
- Works to ensure a diverse and inclusive environment, free from all forms of dis-crimination and harassment
Key Performance Indicators:
- Meeting the registration submission due dates for products planned for launch each year
- Meeting the registration approval dates for products planned for launch each year
- Meeting product re-registration due dates and ensuring that no adverse impact occurs due to loss of license
- Maintaining minimum of 95% DRAGON compliance in update of new received post distribution changes to normal country folders and brand safety folders
- Keeping and improving strong relations with Health Authority’s officials
Impact on the organisation:
- Achievement of new product registration to ensure new launches which in turn contribute to the growth of the company. Maintenance of product licenses to avoid loss of Top line. Ensuring regulatory compliance of portfolio in the country so as to avoid recalls or audit issues due to non-compliance.
Qualification
In respect of the ideal candidate profile:
- Minimum Education: Pharmacy degree with or without postgraduate qualifications
- Desired Education: Courses in ICH Guidelines in Stability Studies and Validation.
Experience
- Minimum of 3 years experience as an associate and 2 years as senior associate in regulatory affairs dealing with a wide variety of registration projects and issues. The Regulatory manager would be expected to have achieved a high level of credibility with key members of the Therapeutic Goods Administration.
Application Closing Date
18th September, 2014.
How to Apply
Interested and qualified candidates should forward an updated version of their CV to:obijiaku@hamiltonlloydandasscoiates.com
Note: Ensure you write the position as subject of the mail. Only qualified candidates will be contacted. Please read carefully.