Vacancy title:
Regulatory Expert

[ Type: FULL TIME , Industry scientific ance, Category: Information Technology]

Jobs at:
BioNTech SE

Deadline of this Job:
30 June 2022

Duty Station:
Within Rwanda , Kigali, East Africa

Summary
Date Posted: Thursday, June 22, 2022 , Base Salary: Not Disclosed

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Learn more about BioNTech SE
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JOB DETAILS:
Regulatory Expert*

Who We Are
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 towards 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.


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


Your Main Responsibilities Are
• 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

Education

What you have to offer.
• 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.
Benefits & Compensation.

We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.




Work Hours: 8

Experience in Months: 60

Level of Education:degree

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.

We are looking forward receiving your application.
• BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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