Regulatory Writer

Job title:

Regulatory Writer

Company:

Ferring

Job description

Job Description:Do you have deep insight into regulatory affairs concerning the clinical and non-clinical aspects of drug development? Are you seeking an exciting job in an international company with excellent development possibilities and opportunities to work with innovative biological pharmaceuticals?As our new regulatory writer, you will write and review high quality non-clinical and clinical documentation as well as help set the high quality standards for our documentation submitted to regulatory authorities.Working on a range of pharmaceutical products across our therapeutic areas (reproductive and women’s health, gastroenterology, and urology), you will collaborate closely with the relevant regulatory colleagues in the therapeutic areas to drive and ensure timely readiness for regulatory submissions.Ferring + youThis position is newly established within our Global Regulatory Affairs department, where you will become part of our Regulatory Writing team. We are responsible for global regulatory writing during development, worldwide market expansions and product lifecycle activities.Collaboration and knowledge-sharing are crucial to your success in this role, so you will work closely with your colleagues within Global Regulatory Affairs, our global R&D functions, Ferring affiliates and development sites worldwide.Your day at FerringYour primary responsibility will be to take the lead in preparing briefing packages related to clinical and non-clinical questions and background information intended for consultations with regulatory authorities, ensuring documents with a clear storyline and the appropriate level of details. You will work closely with project key stakeholders within the nonclinical and clinical disciplines to prepare these high-quality documents.You will spend the majority of your time:

• Drive the authoring of documentation for authority consultations, mainly with a clinical and non-clinical scope
• Ensure close collaboration with relevant subject matter experts across various functions when authoring briefing packages.

Less frequent tasks include authoring and/or review regulatory core labelling texts, e.g., Core Summary of Product Characteristics (SMPC) and Company Core Data Sheet (CCDS) and drive the authoring of response documents upon receipt of questions/requests from regulatory authorities.Your workplace will be our spectacular and state-of-the-art offices, Soundport, near Copenhagen Airport, but you will also have the option of working from home up to two days a week.Behind our innovation – there’s youYou have the experience to drive and plan your projects independently, and you are comfortable working in a dynamic regulatory environment. You strive for high quality in your work while being able to deal with ambiguity.Because of your collaborative nature, you thrive in finding innovative solutions and are keen on working in a multicultural corporate setting.To succeed in this role, you:

• Preferably have 2-4 years’ experience of regulatory/technical scientific writing or other relevant experience pharmaceutical industry in authoring regulatory documentation for submission to authorities with a clinical or non-clinical scope, e.g. briefing packages
• Preferably have a total of 5 years’ experience with non-clinical and clinical drug development and good regulatory knowledge (e.g. key documentation, submissions and approval processes)
• Have a master’s degree in life science (e.g. life science, health or medical sciences)
• Have excellent communication skills in English (written and verbally)
• Exhibit flexibility as well as ability to prioritise and manage multiple projects

People come first at FerringYou will work in a highly engaging environment where you will interface with many different disciplines.Our philosophy of ‘people come first’ flows through every part of the business. Our future is shaped by a science-driven approach, a passion to lead, and our need to collaborate and develop long-lasting relationships to ensure our focus remains on innovation.We succeed in making a difference in the lives of millions of people by working together. Our diverse backgrounds, experiences, expertise and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions.Behind our purpose – there’s youIf our mission and your vision are aligned, please apply. Kindly include a few lines regarding your motivation for applying in the CV or a cover letter. Please note that we review applications continuously and close the process when we find the right match.If you have questions about the role, please reach out to Jens Ekelund, Director, Global Regulatory Affairs Compliance Excellence, +45 28787641.If you have questions about the recruitment process, please contact Talent Acquisition Partner Mette Markussen at .We are unable to offer relocation assistance for this position. Candidates must be located in the Oresund region or willing to relocate at their own expense.Note to agencies: this search is being managed by Ferring’s Talent Acquisition team. Kindly do not send us unsolicited profiles.At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world. Read more at ferring.com.Location: Ferring Denmark

Expected salary

Location

Kastrup, Hovedstaden

Job date

Fri, 05 Apr 2024 22:59:16 GMT

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