location_onCambridge, England, United Kingdom
watch_later Posted: Oct 17, 2024
Skills Required
Nice To Have skills
Job Description
As an Associate Director, Regulatory Affairs, you are an integral part of MoonLake’s team and will be responsible for developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s).
You will be responsible for regulatory aspects related to product development and approval, in alignment with the global business strategy and in partnership with the functional subject matter experts within MoonLake.
Key Responsibilities:
Your profileYou will be responsible for regulatory aspects related to product development and approval, in alignment with the global business strategy and in partnership with the functional subject matter experts within MoonLake.
Key Responsibilities:
- Work with functional colleagues and project teams to develop and implement regulatory strategies enable earliest possible approval, in line with business objectives
- Support interactions with global regulatory interactions 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 appropriate responses to regulatory agency questions with relevant colleagues
- Identification and assessment of regulatory risks and implementation of strategies to minimize risks.
- Provide expert advice to internal teams on regulatory issues as they arise
- Ensure up-to-date knowledge with regard to guidelines and regulatory trends.
- Maintain a thorough knowledge of specific diseases, including a detailed understanding of competitor activities and the prevailing medical practice
- Lead/support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities
- Partner with Regulatory Affairs and cross-functional colleagues to understand the regulatory landscape, e.g. regulatory precedents, labeling differences and adapts to changes that may impact MoonLake development programs
Education:
Skills/knowledge/behavioural competencies:
- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g. PhD or Masters) preferred.
- Minimum of 7 years of experience within regulatory affairs in pharmaceutical industry/Biotech industry, ideally in a relevant disease area
- Experience in either:
- Clinical development, ideally in phase 2 or 3 studies in dermatology or rheumatology;
- 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.
Skills/knowledge/behavioural competencies:
- Ability to create and implement innovative regulatory strategies
- Ability to understand and clearly communicate on topics of basic science is essential
- Good knowledge of the drug development lifecycle and regulatory requirements from clinical trials to marketing is required
- Adaptable with the ability to generate creative solutions, identify different and novel ways to find solutions, and adapt to changing priorities and deadlines.
- Highly collaborative, strong relationship building skills with internal and external partners, with a high level of integrity
- Works proactively using solid communication and influencing skills to effectively execute program goals
- Works effectively in a highly complex and fast-paced environment