What this position is all about: We are 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.
What you would be responsible for:
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.
What experiences we are looking for:
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 at least 3 days a week strongly preferred.
What sets you apart:
Regulatory experience and knowledge across various therapeutic areas.
Strong collaborator with multi-disciplinary teams
Creative problem-solving and critical thinking capabilities