Global Regulatory Affairs Director
1 day ago
MoonLake Immunotherapeutics seeks a highly skilled Global Regulatory Affairs Director to lead the development and implementation of innovative global regulatory strategies for sonelokimab lead indication(s).
This role will be responsible for regulatory aspects related to product development and approval, aligning with the global business strategy and partnering with functional subject matter experts within MoonLake.
Key Responsibilities:- Develop and implement regulatory strategies to enable earliest possible approval, in line with business objectives.
- Support interactions with global regulatory bodies to facilitate approval of all regulatory submissions for sonelokimab.
- Coordinate the preparation, review, and submission of regulatory dossiers to support clinical studies, marketing applications, and scientific advice.
- Coordinate responses to regulatory agency questions with relevant colleagues.
- Identify and assess regulatory risks and implement strategies to minimize risks.
- Provide expert advice to internal teams on regulatory issues.
- Ensure up-to-date knowledge of guidelines and regulatory trends.
- Maintain a thorough knowledge of specific diseases, including competitor activities and prevailing medical practice.
- Lead the development of processes, SOPs, and other controlled documents, including for Regulatory Affairs activities.
- Minimum of 10 years of experience in regulatory affairs in the pharmaceutical industry or biotech industry, ideally in a relevant disease area.
- Experience in clinical development, ideally in phase 2 or 3 studies in dermatology or rheumatology, or nonclinical development, including designing pharmacology, pharmacokinetic, and toxicology studies.
- Experience in working globally and dealing with FDA and/or EMA and national health authorities, from clinical development programs to marketing authorization and scientific advice.
- A dynamic and innovative company pushing the boundaries of possibility.
- A chance to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
- A healthy work-life balance while making meaningful contributions to our team.
- A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
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