Senior Manager, Regulatory Affairs

Permanent employee, Full-time · UK, Portugal

Job Purpose

As a Senior Manager, 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;
- 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 look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:

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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About us

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.

We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.

Further information is available at www.moonlaketx.com

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We are looking forward to hearing from you!

Thank you for your interest in MoonLake Immunotherapeutics AG. Please fill out the following short form. Should you have difficulties with the upload of your data, please send an email to careers@moonlaketx.com .