Vacancy title:
SSR-BNT-REX-Regulatory Expert

[ Type: FULL TIME , Industry: Health Care, Category: consulting]

Jobs at:
Q-Sourcing Servtec Group

Deadline of this Job:
05 July 2022

Duty Station:
Within Rwanda , Kigali , East Africa

Summary
Date Posted: Saturday, June 25, 2022 , Base Salary: Not Disclosed

Similar Jobs in Rwanda
Learn more about Q-Sourcing Servtec Group
Q-Sourcing Servtec Group jobs in Rwanda

JOB DETAILS:
SSR-BNT-REX-Regulatory Expert
Who we are:
As BioNTech, We are a global immunotherapy company. Our 3,000+ colleagues globally are committed to improving the health of people worldwide with our fundamental research utilizing the full potential of the immune system to fight cancer, infectious diseases, and other serious diseases. We leveraged our mRNA technology to develop a COVID-19 vaccine which became the first mRNA drug approved for human use.

What we do with the BioNTainers:
We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA-manufacturing facilities based on a container solution called “BioNTainers”. The aim is to build a regional manufacturing network in Africa, with Africa, for Africa.

Why we need you:
The BioNTainers will be equipped to produce a range of mRNA-based vaccines targeted toward the needs of African Union member states. You will become part of the regional staffing team, driving the establishment of the regional African end-to-end mRNA manufacturing network.

Role Purpose:
Provide strategic and operational regulatory expertise with focus on Rwanda which includes information to register a new vaccine. Accountable to work with the Global Regulatory Lead and Global Quality to develop a valid process and deliver marketing authorizations for our products in Rwanda.

Tasks:
• Close collaboration to the global regulatory organization to ensure that local processes are in line with global defined standards
• Initial contact with local Rwandan authorities
• Preparation of documentation for upcoming monitoring of commercial production
• Act as Regulatory Expert as part of the Rwanda Site and linked to the global regulatory organization
• In alignment with the Global Regulatory Lead (GRL) and Global Quality, define and execute co-development regulatory strategy to enable manufacturing start in Rwanda; assess the test needs and determine the regulatory strategy
• Act as local interface to official Rwandan authorities on behalf of BioNTech ensuring alignment between objectives and timelines
• Plan, prepare and conduct interactions with Health Authorities (e.g. CDRH, EMA, Notified Bodies etc.) as appropriate in coordination with Legal Manufacturers
• Monitor regulatory and competitive landscape in Rwanda; analyze the impact of drug-device regulation changes for BioNTech’s products; collect, evaluate and disseminate relevant updates as appropriate. Provide regulatory advice to global stakeholders in support of strategy development
• Refine existing processes to continuously improve organizational efficiency for Rwanda

Qualifications
Education:
PhD/Masters degree in relevant scientific discipline (e.g., Biology, Chemistry)

Professional experience:
• 5-8+ years of experience in regulatory affairs within the biotech or pharmaceutical industry, vaccine development, therapeutic developments.
• Regulatory, GMP, (module 31 / CMC), legal requirements experience

Languages:
• Fluency in English (written and spoken) is essential

Competencies:
• Significant experience and successful leadership in regulatory aspects (confident, proactive).
• Strong understanding of pharmaceutical business and regulatory governance/framework.
• Good knowledge of existing regulatory processes (including interpretation skills).
• Experience in cooperation with external governmental partners (e.g., official authorities) – good diplomacy and negotiation skills to meet business needs and interests to defend and represent all stakeholders.
• Experience in hosting and collaborating with national or international regulatory agencies.
• Experience in leading global teams.
• Outstanding communication skills (verbal, written, face to face).
• Ability to conceptualize, analyze, plan and manage in a fast-paced environment.
• Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
• Ability to navigate through ambiguity and rapid growth and adapt to change.


Work Hours: 8

Education Requirement: Bachelor’s degree

Experience in Months: 60

Job application procedure
Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.

Please note:
• Only applications sent via our online form shall be considered.
• Only Candidates with the right qualifications and relevant experience shall be shortlisted and
• Incomplete applications shall be rejected.

All Jobs

                                             QUICK ALERT SUBSCRIPTION