Regulatory Affairs Director

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 over $700 millionin funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300 employees.

The Role:

We are seeking a Regulatory Affairs Director to provide strategic leadership and operational oversight for regulatory activities related to the development and approval of our biologic therapies. This individual will play a pivotal role in shaping and executing global regulatory strategies, leading interactions with regulatory agencies, and ensuring compliance with all applicable regulations. The ideal candidate will have a strong background in regulatory affairs, with specific expertise in initial IND filings and regulatory interactions. Depending on the candidate's experience and business needs, the role may also involve additional responsibilities in regulatory CMC product development.

Here's how you will contribute:

• Develop and execute comprehensive global regulatory strategies to support the development, approval, and commercialization of biologic therapeutics.
• Serve as the primary regulatory representative in cross-functional teams, providing strategic guidance and risk assessment.
• Lead the planning and execution of regulatory applications, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and Biologics License Applications (BLAs).
• Provide regulatory expertise for product development, including CMC, nonclinical, and clinical aspects.
• Oversee the preparation, review, and submission of high-quality regulatory dossiers, including briefing books, meeting requests, and responses to health authority questions.
• Ensure compliance with US, EU, and ICH regulatory requirements throughout the product development lifecycle.
• Collaborate with Regulatory Operations vendor to ensure efficient electronic submissions (eCTD).
• Maintaining archival of submissions and health authority communications in Veeva RIM system.
• 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 CMC product development responsibilities depending on experience.
  
  

The Ideal Candidate will have:

• 10 years in the biotechnology/pharmaceutical industry with a minimum of 8 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 biologic drugs. Expertise in oncology and/or immunology and inflammation therapeutic areas is 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 is a plus.
  
  

Location: Open to 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.