Senior Manager of CMC Regulatory, Relay Therapeutics
Office located in Cambridge, MA
AI-driven drug discovery platform
Open for applications
AI-driven drug discovery platform
201-500 employees
Open for applications
Office located in Cambridge, MA
201-500 employees
Company mission
Relay Therapeutics' mission is to create new possibilities in drug discovery focused on precision oncology and genetic disease through its AI and ML-driven computing approaches.
Role
Who you are
- Strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions
- Proven ability to lead and manage regulatory CMC projects
- In-depth knowledge of global CMC regulatory requirements and guidelines (e.g. FDA, EMA, ICH)
- Positive attitude, energetic and proactive
- Strong technical writing and document review skills
- Excellent organizational skills, ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure
- Strategic thinking capabilities with forward looking perspective and ability to find solutions, in alignment with management and program goals, strong communication, planning, and collaboration skills
- Attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties
- Ability to effectively manage multiple projects with competing priorities
- Bachelor or advanced degree in Pharmaceutical Sciences, Chemistry or related fields
- Minimum of 6-8+ years of relevant experience in regulatory-CMC or within CMC function (e.g. analytical, formulation and process development, QA, QC) in the biotech/pharmaceutical industry with a focus on CMC for small molecules
- Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD development/maintenance
- Knowledge of eCTD Module 3 and QOS requirements for INDs/IMPDs and NDAs/MAAs
- Authoring experience of CTD Module 2 & Module 3 sections
What the job involves
- As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs
- Position requires weekly onsite presence
- You will serve as CMC-regulatory lead for assigned projects
- Develop and execute CMC global submission plans and timelines in accordance with project goals
- You will lead the preparation/plans, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA and other global regulatory filings including IB, DSUR, annual updates, briefing books etc. in conjunction with regulatory affairs and CMC/Pharmacetical Development teams
- You will be responsible for coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs teams
- You will lead CMC-regulatory activities listed above with cross-functional teams and act as the regulatory CMC liaison between CMC, regulatory affairs and/or program management, as applicable
- You will lead and manage regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, in conjunction and consultation with CMC leadership
- You will keep abreast of regulatory guidance and technical/scientific developments relevant to projects
Our take
Discovering new drugs is essential in improving how diseases are treated, but existing methods are outdated. Many diseases are highly complex and have so far been impossible to treat with drugs, but developments in AI-driven computing present the potential to change this.
Relay Therapeutics provides an AI-driven drug discovery platform called Dynamo that uses cutting-edge experimental computational approaches to identify disease treatments that have previously been deemed untreatable. The platform's AI approach is driven by a pipeline of therapeutic candidates which hold an initial focus on precision oncology and genetic disease treatment.
AI is being used within the medical industry to aid in a wide variety of scenarios such as facility optimization and automated diagnoses, but Relay Therapeutics has smartly applied it to drug discovery. Through this more targeted approach, the company aims to rapidly develop genetic disease treatments and optimize the process of precision oncology, with plans to expand into further disciplines in the future. It's continued development of new products shows that Relay is keeping up the pace.
Steph
Company Specialist at Welcome to the Jungle
Insights
9% employee growth in 12 months
Company
Funding (last 2 of 3 rounds)
Dec 2018
$400m
SERIES C
Dec 2017
$63m
SERIES B
Total funding: $520m
Company benefits
- Medical coverage
- Dental coverage
- Vision coverage
- Life, AD&D, and disability insurance
- Flexible spending accounts
- 401K retirements savings
- Commute reimbursements
- Parental benefits
- Time off and vacation
Company values
- The little things really matter to us - we sweat every detail because we know it makes the difference time after time
- We're candid with each other - we have a responsibility to look into each other's eyes and agree, disagree, challenge, and succeed together
- We take great pride in our culture - come as you are because we embrace quirkiness. In fact, we thrive on it
- We value and respect different experiences - our inclusive culture encourages people to openly share their points of view
Company HQ
Wellington-Harrington, Cambridge, MA
Articles
Leadership
Mark Murcko
(Founder)Principal at Disruptive Biomedical, LLC since 2011. Senior Lecturer at the Department of Biological Engineering for MIT since 2012.
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