Regulatory Affairs Director

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time
Job Description

Company Overview: Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.

We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains. Our mission is to provide innovative solutions for businesses and professionals in the industry.

Salary

The estimated salary for this position is $120,000 - $180,000 per year, depending on experience and qualifications.

Job Description

As an Associate Director, Regulatory Affairs at Lifelancer, you will be responsible for developing and delivering innovative global regulatory strategies for our clients' products. You will work closely with functional colleagues and project teams to develop and implement regulatory strategies that enable earliest possible approval, in line with business objectives.

You will also support interactions with global regulatory authorities to facilitate approval of all regulatory submissions for our clients' products. Additionally, you will coordinate the preparation, review and submission of regulatory dossiers to support clinical studies, marketing applications and scientific advice.

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 authorities to facilitate approval of all regulatory submissions for our clients' products.
  • 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 Lifelancer's development programs.

Your Profile:

  • 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.
Required Skills and Qualifications

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.
Benefits

Lifelancer offers a comprehensive benefits package, including competitive salary, bonuses, health insurance, retirement plan, and paid time off.

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