Vice President of Regulatory Affairs
Job DetailsVaccitech plc is a fast-growing biotech company headquartered in Harwell, UK, and listed on Nasdaq in the United States.
At only seven years old we already have a development portfolio of nine programmes, a partnered product that is in commercial production which has seen more than 3 billion doses administered worldwide and an IPO behind us.
We are a publicly-listed clinical stage biopharmaceutical company that spun out of the University of Oxford's Jenner Institute, one of the most prestigious vaccine research centres in the world.
We discover and develop immunotherapeutics for the treatment and prevention of infectious diseases, autoimmune diseases and cancer.
Our achievements include co-inventing and jointly developing our COVID-19 vaccine, Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca.
We have ongoing clinical studies exploring treatments for patients with HBV, HPV and prostate cancer, and have pre-clinical programs in coeliac disease and HPV cancer.
We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.
The Role Devise, execute, and maintain comprehensive regulatory strategies to support global clinical trials, product registrations and approvals.
Strategic leadership of the global regulatory affairs team.
Build and nurture relationships with Health Authorities for successful interactions and outcomes, acting as the company's primary point of contact.
Act as an independent subject matter expert to various project teams and departments, with particular close collaboration with the clinical operations and research departments.
Keep abreast of global regulatory requirements and assessing risks, developing contingency plans.
Overseeing coordination of regulatory submissions, strategizing for dossier updates, and submission of new INDs/CTAs/NDAs/MAAs.
Support cGXP activities related to regulatory affairs, like inspections.
Actively participate on project teams providing regulatory strategy, guidance and compliance oversight for Vaccitech's product candidates.
Identify and assess regulatory risks for assigned projects or programs.
Qualifications and experience required University degree in a life science subject.
10 to 15
years experience in global Regulatory Affairs, particularly UK and China, with US being beneficial.
Vaccines, infectious disease and oncology experience beneficial.
Demonstrated leadership qualilities.
Strong relationships with the Health Authority.
Proven expertise in regulatory submission and approval processes, and in resolving complex CMC regulatory issues.
Strong interpersonal, organizational, communication, presentation, negotiation, and problem-solving skills.
Culturally sensitive with the ability to lead a global team across different time zones.
Notice to recruitersVaccitech's internal Talent Acquisition leads recruitment and employment for Vaccitech.
Unsolicited resumes sent to Vaccitech from recruiters do not constitute any type of relationship between the recruiter and Vaccitech and do not obligate Vaccitech to pay fees should we hire from those resumes.
Vaccitech operate a preferred list of recruitment suppliers, any and all equiries about joining us as a supplier should be directed to Vaccitech's TA Team.
We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees.
Recommended Skills Biology Clinical Trials Clinical Works Communication Diversity Awareness Immunization Estimated Salary: $20 to $28 per hour based on qualifications.
At only seven years old we already have a development portfolio of nine programmes, a partnered product that is in commercial production which has seen more than 3 billion doses administered worldwide and an IPO behind us.
We are a publicly-listed clinical stage biopharmaceutical company that spun out of the University of Oxford's Jenner Institute, one of the most prestigious vaccine research centres in the world.
We discover and develop immunotherapeutics for the treatment and prevention of infectious diseases, autoimmune diseases and cancer.
Our achievements include co-inventing and jointly developing our COVID-19 vaccine, Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca.
We have ongoing clinical studies exploring treatments for patients with HBV, HPV and prostate cancer, and have pre-clinical programs in coeliac disease and HPV cancer.
We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.
The Role Devise, execute, and maintain comprehensive regulatory strategies to support global clinical trials, product registrations and approvals.
Strategic leadership of the global regulatory affairs team.
Build and nurture relationships with Health Authorities for successful interactions and outcomes, acting as the company's primary point of contact.
Act as an independent subject matter expert to various project teams and departments, with particular close collaboration with the clinical operations and research departments.
Keep abreast of global regulatory requirements and assessing risks, developing contingency plans.
Overseeing coordination of regulatory submissions, strategizing for dossier updates, and submission of new INDs/CTAs/NDAs/MAAs.
Support cGXP activities related to regulatory affairs, like inspections.
Actively participate on project teams providing regulatory strategy, guidance and compliance oversight for Vaccitech's product candidates.
Identify and assess regulatory risks for assigned projects or programs.
Qualifications and experience required University degree in a life science subject.
10 to 15
years experience in global Regulatory Affairs, particularly UK and China, with US being beneficial.
Vaccines, infectious disease and oncology experience beneficial.
Demonstrated leadership qualilities.
Strong relationships with the Health Authority.
Proven expertise in regulatory submission and approval processes, and in resolving complex CMC regulatory issues.
Strong interpersonal, organizational, communication, presentation, negotiation, and problem-solving skills.
Culturally sensitive with the ability to lead a global team across different time zones.
Notice to recruitersVaccitech's internal Talent Acquisition leads recruitment and employment for Vaccitech.
Unsolicited resumes sent to Vaccitech from recruiters do not constitute any type of relationship between the recruiter and Vaccitech and do not obligate Vaccitech to pay fees should we hire from those resumes.
Vaccitech operate a preferred list of recruitment suppliers, any and all equiries about joining us as a supplier should be directed to Vaccitech's TA Team.
We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees.
Recommended Skills Biology Clinical Trials Clinical Works Communication Diversity Awareness Immunization Estimated Salary: $20 to $28 per hour based on qualifications.
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