Associate Director, Regulatory Affairs

4 days ago

Cambourne, United Kingdom Moonlake Immunotherapeutics Full time

Job Purpose 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: 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.
Your Profile Education: Minimum of first degree in life sciences (or equivalent); advanced degree (e.g.
PhD or Masters) preferred.
Experience: 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; 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.
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.
Why Us?
An exciting job opportunity awaits
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.
What We Offer: Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
Our Core Values: We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.
We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
We unlock value: We aspire to create long-term value for investors and communities.
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