Senior Regulatory Scientist, Life Cycle Management - Unique Human Capital
Unique Human Capital A/S
Drive the future of life-saving products by shaping regulatory strategies and ensuring seamless compliance at every stage of the lifecycle
As Senior Regulatory Scientist, LCM at Voisin Consulting Life Sciences (VCLS), you will play a crucial role in supporting Life Cycle Management (LCM) activities for clients, ensuring regulatory compliance for products already on the market.
With a direct report to the Group Leader, you will focus on developing and executing regulatory strategies, leading interactions with regulatory authorities, and supporting product lifecycle.
Your main tasks are (and not limited to):
- Oversee LCM activities, focusing on managing the regulatory aspects of marketed products.
- Develop and execute regulatory strategies for assigned projects.
- Prepare and submit regulatory filings.
- Lead communications with regulatory agencies to obtain approvals for clinical trials and marketing applications.
- Represent the client in meetings and discussions with external stakeholders.
- Work on client sites from time to time.
Your qualifications are a minimum of five years of experience in regulatory affairs, with a focus on Life Cycle Management within the pharmaceutical, biotech and/or consulting industry. Previous experience interacting with regulatory authorities, managing submissions, and ensuring compliance with US and EU pharmaceutical regulations is essential.
You have a master’s or bachelor’s degree in life science or equivalent, for example, pharmacist, pharmacologist, bioproduction engineer, doctor, etc.
You are a person with good organisational and interpersonal skills, the ability to manage multiple projects and priorities, and the ability to work with tight deadlines while being collaborative and consultative with clients and colleagues.
Voisin Consulting Life Sciences offers a flexible workplace and good work-life balance with individual working hours agreements. You will be involved in exciting projects with clients with huge potential to develop personally and professionally.
Travelling: A few days a year for events. Working on-site with clients from time to time is part of the job.
Domicile: Copenhagen, Denmark.
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Voisin Consulting Life Sciences (VCLS) guides Biotech, Pharma and Medtech manufacturers throughout product development and commercialisation. VCLS assists innovators in designing product development strategies that optimise clinical development to drive commercial success through an understanding of regulators and payers. The VCLS team understands the clients’ science and business objectives and seamlessly supplements their resources with strategic advice and operational capabilities.
Please read more at https://voisinconsulting.com/ and see this video.
Adresse:
Copenhagen, Denmark
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