Regulatory Specialist at Promasidor

Job Purpose

• To achieve 100% compliance of Processes, Systems and Products with Regulatory MDA’s guidelines, regulations and Laws.

Key Responsibilities

Assist with managing the Regulatory approval process for New Product Registration and Reformulation both with Internal functionaries and NAFDAC:

• Ensure all pre-application required documents involved in the process are vetted and adequately in-line with Regulatory guidelines and regulations as appropriate.
• Manage the following post-application processes: Production Inspection & Audit Exercise, follow up on Laboratory and GMP result releases,
• Engage with NAFDAC to ensure the necessary approvals/communication are received on-time and within the stipulated timelines.

Assist with managing the process of issuance of import permits/permit NAFDAC with the support of the Supply Chain Department:

• Ensure all pre-application required documents involved in the outlined process are vetted and adequately in-line with Regulatory guidelines and regulations as appropriate.
• Manage application post-submission processes to ensure approvals/communication are received on-time and within the stipulated timelines.

Assist with managing Regulatory approval process for Product/Corporate Adverts on desired mediums with NAFDAC Marketing Department:

• Ensure all pre-application required documents involved in the outlined process are vetted and adequately in-line with Regulatory guidelines and regulations as appropriate.
• Manage post-submission of application to ensure approvals/communication are received on-time and within the stipulated timelines.

Assist with managing Regulatory approval process for Change in labels, Pack size extension, Promotional labels with NAFDAC while liaising with Marketing Department for the required support:

• Ensure all pre-application required documents involved in the outlined process are vetted and adequately in-line with Regulatory guidelines and regulations as appropriate
• Manage post-submission NAFDAC post-submission of application to ensure approvals/communication are received on-time and within the stipulated timelines.

Assist with managing the process of MANCAP certification and revalidation with SON:

• Ensure all pre-application required documents involved in the outlined process are vetted and adequately in-line with SON regulations and Standard.
• Follow up with the Agency on the post-application progress and ensure proper communication is received on developments and approvals.

Assist with managing approval process for Consumer Promotion with FCCPC and NLRC:

• Liaise with Marketing Dept to ensure that all documents required to process the needed approvals are available and properly vetted before such is submitted to the Agency.
• Follow up application progress with the agency to ensure proper communication is received on developments and process approval.

Assist with managing activities with other Regulatory Agencies-Weights & Measure(W&M), NESREA, LASEPA, FMoH:

• Ensure prompt renewal of Weights & Measure Certificate.
• Support HSE Department, when necessary, in managing activities of NESREA, LASEPA, FMoH.

Manage Insurance Portfolios for PNG & IDF:

• Manage all company Insurance portfolios-IAR’s, Motor Vehicle, CMFL, GIT, D&O, Cattle & Burglary Insurance.
• Manage all Insurance claims to ensure company is adequately and timely indemnified.
• Manage Insurance prompt portfolio renewals.
• Manage communications between the company and it’s insurers.
• Represent the company in all Insurance activities with Ministries, Departments and Agencies

Job Requirements

• B.Sc. (Hons) in Microbiology, MNIFST, MCIIN, MBA-in-view
• Minimum of 3 years experience in a similar role, preferably FMCG