Regulatory Affairs Senior Manager

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with over 275 employees.

The Role: 

We are seeking a dedicated and experienced Regulatory Affairs Senior Manager to join our team. This individual will play a crucial role in supporting our regulatory strategies and submissions to ensure compliance with US, EU, and ICH regulatory requirements. The successful candidate will work closely with the Senior Director of Regulatory Affairs and various cross-functional teams to facilitate the development, communication, and execution of regulatory strategy and submission timelines. Depending on the candidate's experience, the role may also involve additional responsibilities in regulatory CMC product development.

Here's how you will contribute:

• Managing the preparation of regulatory filings including Investigational New Drug applications (INDs)/Clinical Trial Applications (CTAs)
  • Creating timelines and coordinating regulatory filings 
  • Providing and maintaining templates for authoring of regulatory documents; such as briefing books, meeting requests, Fast-track and Breakthrough therapy requests 
  • Overseeing authoring, reviewing and format as needed of regulatory documents 
  • Ensure the content of the regulatory submission is complete and ready to go to publishing
  • Providing final documents to CRO or publishing company for submission 
  • Prepare cover letters and submission packets 
• Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Orphan Drug Designation applications, US FDA Fast Track applications, Investigational New Drug (IND) applications, Protocols, Clinical Study Reports, Briefing Books, DSURs, etc.) and completing regulatory documents/forms for internal review and submission.
• Collaborate with Reg Operations to provide final documents and QC published outputs for submissions to HA
• Maintaining archival of submissions and health authority communications in Veeva RIM system
• Providing regulatory updates to the project, clinical development and operations, nonclinical, and CMC teams.
• Contribute to the development of department policies, procedures (RA SOPs), and best practices commensurate with the requirements of a rapidly growing company.
• The role may also take on additional Regulatory CMC product development responsibilities depending on experience.

The Ideal Candidate will have: 

• 8+ years in the biotechnology/pharmaceutical industry with a minimum of 6+ years spent in Regulatory Affairs.  Manager level candidates will be considered with 6 years of biotechnology/pharmaceutical experience and 4+ years spent in Regulatory Affairs.
• Bachelor’s degree (required), with an advanced degree in a scientific discipline preferred.
• Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
• Strong interpersonal skills and problem solving/decision making skills.
• Demonstrates the ability to work independently as well as a team member
• Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
• Experience supporting regulatory submissions for drugs and/or biologics, with biologics experience preferred.
• Experience with eCTD requirements and electronic submissions
• Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities
• Experience with early development programs is preferred.
• Experience with Veeva RIM is a plus
• Background in regulatory CMC, with experience in preparing Module 3 and IMPD-Quality sections for regulatory submissions and familiarity with current Good Manufacturing Practices (cGMP) and quality guidelines will be highly regarded.

Location: Remote; travel required to Somerville, MA office as business dictates.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

COVID Safety:

Generate:Biomedicines enforces a mandatory vaccination policy for COVID-19. All employees must be fully vaccinated and have received a booster.  The purpose of this policy is to safeguard the health of our employees, their families, and the community at large from infectious disease that may be reduced by vaccinations.  The Company will make exceptions to this policy if required by applicable law and will consider requests for an exemption from this policy due to a medical reason, or because of a sincerely held religious belief, or any other exemptions that may be recognized by applicable.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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