- Lead and support preparation of high-quality global regulatory submissions including IND applications to support early-stage clinical development activities.
- Provide input into the design of clinical trial protocols to ensure they meet regulatory requirements.
- Review and approve protocols to ensure they align with the regulatory strategy.
- Establishing and maintaining effective communication with regulatory agencies.
- Coordinate key interactions with health authorities and facilitate communication of feedback to internal program and clinical development teams.
- Function as regulatory representative on cross functional program teams and meetings with external partners such as CROs.
- Work closely with program teams to ensure timely execution of regulatory milestones.
- Anticipate potential challenges in obtaining regulatory approval and developing strategies to mitigate these risks.
- Bachelor's degree in a scientific discipline; Advanced degree preferred.
- Minimum of 7 years of experience in regulatory affairs within the biotech/pharmaceutical industry. Biotech experience preferred.
- Demonstrated experience in authoring and preparing IND submissions.
- Experience as primary regulatory author for IND and CTA documents
- Strong knowledge of US and EU regulations and guidelines pertaining to the conduct of investigational drug studies; further global experience would be a plus.
- Experience managing external teams at CROs and driving execution against key deliverables.
- Ability to work across a number of disease areas.
- Excellent communication skills with the ability to collaborate effectively across functions.
- Ability to be on-site in Somerville, MA at least 3 days a week strongly preferred.
- Regulatory experience and knowledge across various therapeutic areas.
- Strong collaborator with multi-disciplinary teams
- Creative problem-solving and critical thinking capabilities
- Push Boundaries: We create a legacy with breakthrough science in service of patients.
- Inject Energy: We build strengths from different perspectives and tell it like it is.
- Own it: We transcend our job descriptions and relentlessly follow through on our commitments.
- Go all out: We work quickly and with conviction.
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Director, Regulatory Affairs - Somerville, United States - Flagship Pioneering
Description
What if you could join a company rapidly advancing its first candidate to clinic and play a critical role in bringing new medicines to patients through looking at and treating disease in a revolutionary way?
What if you could be the first hire in Regulatory Affairs with the opportunity to build a strategy and your team as we expand our clinical pipeline?
What this position is all about : Cellarity is looking for a strategic and results-driven Head of Regulatory Affairs (level commensurate with experience) to lead our regulatory efforts and activities for the advancement of our assets through early clinical development. This individual will play a pivotal role in shaping the regulatory strategy, ensuring compliance, and facilitating communication with regulatory authorities. This role will also navigate the regulatory landscape and ensure compliance with regulatory requirements. Role with report into Head of Translational Medicine.
What you would be responsible for:
What experiences we are looking for:
What sets you apart:
What it's like to work at Cellarity:
At Cellarity, we
Company Summary: Cellarity's mission is to fundamentally redesign the way drugs are created for the sake of bringing new hope to patients. By shifting the focus from a single target to the underlying cellular dysfunction, we unravel the complexity of disease biology and create medicines that were never before possible. The company has developed unique capabilities that link biology and chemistry with high dimensional -omics data from which we design medicines against the cellular signature of disease. The Cellarity platform allows us to uncover new biology in diseases even in the absence of known causal targets. The company has drug discovery programs underway in several disease areas, including metabolic disease, hematology, and immunology. Cellarity recently completed a Series C financing and has raised a total of $274M from all funding rounds to date, with contributions from world-renowned investors alongside Flagship Pioneering who created the company. Cellarity's goal is to grow into a fully integrated, clinical phase, next generation Biotech company driving a new age in drug creation.
Cellarity 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.
Recruitment & Staffing Agencies : Cellarity does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Cellarity or its employees is strictly prohibited unless contacted directly by Cellarity's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Cellarity, and Cellarity will not owe any referral or other fees with respect thereto.
