Regulatory Affairs - Boston, MA, United States - Verily

Description

Verily is a subsidiary of Alphabet that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered.

Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every day.

We are focused on generating and activating data from a variety of sources, including clinical, social, behavioral and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence.

Our unique expertise and capabilities in technology, data science and healthcare enable the entire healthcare ecosystem to drive better health outcomes.

Within the Clinical Studies Platforms (CSP) business line, our foundational work was Project Baseline, a 360-degree evaluation of health through data.

Project Baseline is expanding from a single study into a superior full-scale evidence generation platform. Verily intends to rewrite the textbook on how clinical research studies are planned, executed, analyzed and interpreted.

In this vision, all people will have the opportunity to participate in clinical research to improve their own health and contribute to the future.

Data will be maximally leveraged to generate reliable insights.

Tried-and-true clinical trial study designs will be updated with next generation solutions such as incorporating real-world data and artificial intelligence.

While this story starts with a US footprint, international expansion will quickly follow.
The Head of Regulatory Affairs will lead regulatory strategic planning, assessments, submissions, and operations at Verily.

The Head of RA will lead the Verily RA Team to work collaboratively with key stakeholders in support of product development and commercialization for medical devices and precision health products and services around the world.

Possible locations of the role are SSF, Boston, DC, or remote based talent in select circumstances.

Lead and manage the Regulatory Affairs team in the development and implementation of regulatory strategies and processes to secure marketing approvals around the world.

Assist and advise on clinical studies required for regulatory approvals, including clinical study design and data analysis.
Keep senior leadership team informed of regulatory status of products, regulatory strategy and significant regulatory issues.
Foster positive and effective working relationships with regulatory bodies (e.g., Build partnerships with cross functional stakeholders, such as Marketing and Market Access, to incorporate global marketing and reimbursement strategies into regulatory strategy.

Provide technical guidance and training to staff, including on new FDA guidance documents, FDA warning letters, regulatory submission preparation and development of labeling, marketing and promotional materials.

Recruit, retain and develop Regulatory Affairs team members and develop department policies and processes.

BA/BS in a technical or scientific field.
~12+ years of Regulatory Affairs life sciences experience with a preference for experience in pharma, clinical research, and/or biotech.
~ Extensive experience interacting with regulatory bodies; leading, managing and developing regulatory teams; and developing and implementing complex or novel regulatory strategies.
~ Experience working with the FDA at the policy level.

The US base salary range for this full-time position is $230,000 – $346,000 + bonus + equity + benefits.

The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations.

Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

We are a diverse team of builders innovating at the intersection of health and technology—united by a shared spirit of curiosity, resilience and determination to make better health possible for all.

This builder mindset means your fingerprints will be on the work that shapes the future of health.

Fulfilling our precision health purpose starts with the health of our Veeps, which is why we offer flexibility, resources, and competitive benefits to support you in your whole-person well being.

As One Verily, we uphold our collective accountability to sustain this culture and to create a VIBE (Verily's Culture of Inclusion, Belonging, and Equitability) where all Veeps feel included, a sense of belonging, and have opportunities to grow.

You can find out more about our company culture on our LinkedIn Company Page and Verily Careers page.
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