DRA Manager at Hamilton Lloyd and Associates

Hamilton Lloyd and Associates - Our client is a global leader in innovative pharmaceuticals, generics, vaccines and consumer health products, with presence in over 140 countries. They are big on providing healthcare solutions that address the evolving needs of patients and societies- products to prevent and treat diseases, ease suffering and enhance quality life.

The Nigerian office has decided to start the search for a DRA Manager, Nigeria.

Job Title: DRA 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 Novartis 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.

Main Responsibilities:

• To lead, develop and manage DRA 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 Novartis premises license annually with Pharmacists’ Council of Nigeria (PCN) before 31st of January each year
• Develop and maintain good working relationships with other Novartis 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 officialsImpact 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

Requirement/ Qualification

• Pharmacy degree with or without postgraduate qualifications
• Courses in ICH Guidelines in Stability Studies and Validation.
• 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 DRA 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, 2012

Method of Application
Interested candidates should
Forward CVs to: [email protected]

Note: Only qualified candidates would be contacted.