Senior Regulatory Affairs Consultant - Vaccines (mRNA a plus)

Excellent opportunity for an experienced Regulatory Affairs Manager/Senior Manager to bring your talent, excellent communication skills, strategic mindset, and regulatory expertise to Parexel Consulting! This is a tremendous opportunity to work alongside one of the largest global healthcare companies in their pursuit to provide life protecting vaccines globally.

In this highly visible role, you will partner closely with a large multinational pharmaceutical company to ensure the development of appropriate regional regulatory strategy(s) and their execution for multiple INDs for vaccine mRNA candidates across various programs.

As a Senior Regulatory Affairs Consultant, you will:

Draw upon your regulatory expertise and previous FDA interactions to contribute to regulatory strategy, develop next stage meeting materials, and briefing documents and complete various information requests to ensure next milestones are completed specific to mRNA vaccines under development 

Attend global meeting and function as the US representative voice and take part in FDA calls. 

Lead interactions with local / regional regulatory authorities. In performing the role, the job holder will be responsible for:

Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally

Implementation of the regional strategy(s) in support of the project globally

Lead regulatory interactions and the review processes in local region

Ensuring appropriate interaction with regional commercial teams in local region

Ensuring compliance with regional requirements at all stages of product life

To ensure success, a Senior Regulatory Affairs Consultant will have previously demonstrated success in all aspects of the product development process (Exploratory, Pre-Clinical, IND Application, Phase 1, Phase 2, Phase 3 and Licensure), participation in cross functional project teams and experience in the development of regulatory strategies for successful BLA licensure. In depth knowledge and understanding of applicable North American, regulations/guidelines is also expected.

Competencies and Capabilities:

Excellent communication skills, ideally in writing and verbally

Proven ability to deliver key communication with clarity, impact, and passion

Commands attention and interest through use of appropriate communication techniques

Proven ability to foster strong matrix working

Capable of facilitating groups of individuals to work together on creating solutions

Ability to lead change and communicate difficult messages

Able to implement plans and hold self and team accountable for delivery of short- and medium-term goals

Proven ability to build strong personal networks, within Client and use them to secure appropriate support and outcome for a project

Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome

Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions

Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context

Proven ability to make sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints

Shows a constant focus on improving performance and excellence in all tasks

Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets

Experience, Skills and Specialized Knowledge Required

Bachelor’s degree or preferably PhD in biological or healthcare science

Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence

Proven experience of leading regional development, submission and approval activities in local region(s)

Capable of organizing and executing successful milestone meetings and with track record of successful relationships with one or more Health Authority

Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally

Extensive knowledge of vaccine product development

Previous mRNA experience is strongly preferred

This role may require <15% travel to client location in the future as needed

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

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