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Director or Senior Director of Regulatory Affairs Strategy

Employer
Barinthus Biotherapeutics
Location
Germantown, MD
Start date
Feb 15, 2024

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Discipline
Marketing, Regulatory, Regulatory Affairs
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
BioCapital

Job Details

Barinthus Biotherapeutics 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.

Key Responsibilities of Role

•    Lead Global Regulatory Strategy for products at the project team level, accountable for the overall submission strategy and timelines to meet project and company goals.
•    Drive content, format and submission of strategic regulatory documents, related supplements and amendments worldwide, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA.
•    Work with cross-functional teams including Program Management, Safety, Clinical Operations, Regulatory Operations, and CMC to ensure alignment of regulatory strategy with the overall product development plan throughout the clinical development processes (initial application through marketing application).
•    Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/CTA through marketing application).
•    Ability to work both independently and within project teams, committees, etc. to achieve group goals.
•    Oversight of tasks completed by a Contract Service Provider, including accountability for deliverables and budget tracking.
Other Responsibilities of Role
•    Support company and departmental initiatives as needed, including establishment and review of Standard Operating Procedures, audit preparation, regulatory intelligence updates, etc.

Qualifications and/or experience required to perform the role

•    Degree in science or healthcare discipline (required), Masters, Pharm D or PhD (preferred)
•    10+ years of experience in the pharmaceutical industry, 5+ years of experience in regulatory affairs
•    Experience in the regulation of biologics (immunomodulating therapies / vaccines preferred, but not required)
•    Experience working on products in development, specifically relating to clinical and pre-clinical regulatory aspects of the project.
•    Strong experience of procedures and legislation for the requirements for the registration of biologics in the US (required) and world-wide (EMA, MHRA) (preferred).
•    Strong working knowledge of Regulatory Life Cycle Management and eCTD format and content for regulatory filings
•    Experience and knowledge in the drafting and organization of regulatory submissions and supportive amendments or supplements
•    Demonstrate strong organizational skills, including the ability to prioritize workload
•    Excellent written and oral communication skills, 
•    Proficiency with standard Windows and Office programs, experience with electronic document management systems publishing software knowledge preferred.

Notice to recruiters

 

Barinthus Biotherapeutics' internal Talent Acquisition leads recruitment and employment for Barinthus Biotherapeutics. Unsolicited resumes sent to Barinthus Biotherapeutics from recruiters do not constitute any type of relationship between the recruiter and Barinthus Biotherapeutics and do not obligate Barinthus Biotherapeutics to pay fees should we hire from those resumes. Barinthus Biotherapeutics operate a preferred list of recruitment suppliers, any and all equiries about joining us as a supplier should be directed to Barinthus Biotherapeutics' TA Team. We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees.

Company

Barinthus Biotherapeutics plc is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutics that guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer. The company stands apart through its broad pipeline, built around four proprietary platform technologies;ChAdOx, MVA, SNAP-TI and SNAP-CI. These platforms are enabling the company to develop antigen-specific immunotherapeutics that aim to optimize the disease-fighting capabilities of T cells and guide them towards a healthy balance. Leading the way with a passion for science embodies everything we do at Barinthus Biotherapeutics – even our new name. Barinthus was the name of the mythological navigator who guided the legendary King Arthur of Britain by ship to the island of Avalon to be healed after he was wounded. Like Barinthus, our company aims to be a strong and resilient guide, navigating those that rely on us toward better health. In this most important journey, our vessel is the power of science and our expertise to harness it in directing the immune system to help people overcome chronic infectious diseases, autoimmunity, and cancer. While our eyes are keenly focused on moving science forward, we also draw inspiration from the past. Aligning the name of our company with an Arthurian legend is a nod to our rich UK-based history as a dedicated steward of science and unwavering champion of patients. If the past is prologue for the future, then we proudly embrace the values and technological approach that continue to be the hallmark and fabric of our company – now more than ever as we blaze on as Barinthus Biotherapeutics.
 

Company info
Website
Phone
+441865591439
Location
20400 Century Blvd
Germantown
Maryland
US

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