Market Authorization and product registration Specialist

About Pharmakon Trading House PLC

Pharmakon Trading House is a private limited company and one of the major Pharmaceuticals, medical & laboratory supplies, and Hospital equipment importer and distributor; Serve the supply chain of these products to health sector for several years. Currently has more than 100 imported items and wants to expand its company by recruiting competent human man power for the below listed positions. 

Job Summary 

Working with and reporting to the technical manager, The Market Authorization Specialist is responsible for obtaining and maintaining the necessary market authorizations for pharmaceutical products, laboratory reagents, medical devices and equipment’s for various markets. This role involves preparing, submitting, and managing dossiers, regulatory requirements, ensuring compliance with local and international regulatory requirements, and liaising with health authorities. The specialist plays a critical role in enabling the company to introduce new products and maintain the availability of existing products in the market. In general,, the specialist performs:

• Prepare and submit Dossier that Pharmakon wants to register and reregister.

• Coordinate and follow up market authorization applications, variations, renewals, and other regulatory submissions in compliance with local and international regulations.

• Manage timelines and ensure timely submissions to avoid delays in product launches or continued market availability. 
• Comprehensive Knowledge of registration guidelines and preparation of dossier.

SPECIFIC DUTIES AND RESPONSIBILITIES

Under the overall supervision and guidance of technical manager and CEO of Pharmakon trading house, the market authorization specialist Expected to perform with respect to Compliance, Documentation, Liaison’s with health Authorities, Cross functional Collaboration, Risk management and Training and development functions. These details are below listed:

Compliance:

• Ensure that all products meet regulatory requirements throughout their lifecycle, including during the development, approval, and post-marketing phases.

• Monitor changes in regulatory guidelines and implement necessary adjustments to ensure ongoing compliance.

Documentation:

• Prepare and maintain accurate and up-to-date regulatory documentation, including dossiers, product information, labeling, and packaging.

• Ensure that all regulatory submissions are properly documented and archived for future reference. 

• Prepare the dossier with close communication with the Factory, CEO, Regulatory affairs manager and operating manager. And renew the registration as per schedule listed. 

• Prepare database for Register products and renewal schedule.

Liaison with Health Authorities:

• Act as the primary point of contact between the company and health authorities or regulatory bodies.

• Respond to queries from regulatory agencies and provide additional information or clarification as required. 

Cross-Functional Collaboration:

• Work closely with the R&D, Quality Assurance, Manufacturing, and Marketing teams to gather necessary data and ensure alignment on regulatory strategies.

• Provide regulatory guidance and support during product development and throughout the product lifecycle. 

• Handle the registration process of the products registered under Pharmakon trading house Plc.

Risk Management:

• Identify potential regulatory risks in development projects and market submissions and provide solutions to mitigate these risks.

• Keep abreast of industry trends, regulatory changes, and emerging issues that could impact market authorizations.

Training and Development:

• Stay updated on current regulatory trends and practices and share knowledge with colleagues and stakeholders.

• Assist in training other team members on regulatory requirements and procedures.

• Prepare, Revise and update the standard operating procedure for registration of pharmaceuticals, medical devices and equipment’s with reference of EFDA guidelines. 

Department: Regulatory Affairs

Reports To: Technical Manager

Duration of Contract: at least two years with possible extension

Salary: Negotiable.

Required Qualification

• BA degree in Pharmacy Education: Bachelor’s degree in pharmacy, Life Sciences, Regulatory Affairs, or a related field. A master’s degree or certification in Regulatory Affairs is preferred. 
• Knowledge: Strong knowledge of local and international pharmaceutical regulations (e.g., FDA, EMA, ICH guidelines).

 Experience

• 3-5 year of directly relevant experience in the registration of pharmaceutical products and dossier preparation. Experience: Minimum of years of experience in regulatory affairs within the pharmaceutical industry, with a focus on market authorizations.

Required Skills, Attitudes, and Attributes

• Excellent organizational and project management skills.

• Strong attention to detail and ability to work under tight deadlines.

• Proficiency in regulatory submission software and MS Office Suite.

• Effective communication and interpersonal skills, with the ability to work collaboratively across departments.

• Attention to detail, anticipation and follow up are core values of the job function.
• Strong oral and written communication

• Ability to work independently as well as in a team.

• Willingness to attend for regulatory meetings or audits.

• Ability to be flexible and adaptable. 

• Must have analytical and report write skills.

• Assist the Technical manager in reviewing specifications, and undertakes any other duties that may be assigned by the Supervisor. 

• Cooperate to do any tasks related to help the future company growth. 

How To Apply

All interested candidates are encouraged to apply for the position advertised by submitting their CV/Resume (maximum of 3 pages) and application letter (one Page only) to yemisrach12.a@gmail.com or ahme2003@gmail.com; or Via telegram no; +251915608080 no later than 5 working days to this announcement. Please write the position title you are applying for in the email subject line, "Market authorization and registration specialist” / “senior accountant”.

Only candidates that are short-listed will be contacted

Women candidates are highly encouraged to apply.

The candidate must will to adhere and perform as per the Pharmakon Trading Code of conduct and company rules and regulations.