Regulatory & QA Assistant

Regulatory & QA Assistant

As the inventor Alan Kay once said, “The best way to predict the future is to invent it.”

For the role, we value personal skills such as adaptability, communications, and problem-solving. A person with experience from administrative work, preferably within the pharma industry, who is good at organising and keeping an eye on the details, as well as having an interest in IT systems related to the regulatory and quality field. Is that you? Then please apply for this job with us at Ascelia Pharma.

We are looking for a regulatory and quality assurance (QA) assistant, to join our team on our journey to become a commercial stage pharma company. A person who will take a leading role in assisting the regulatory and quality department at Ascelia Pharma, in building the quality system and the global regulatory submissions for products aiming at improving the lives of patients with rare oncology related diseases.

To be successful in this position, you must be able to coordinate, prioritize and sometimes foresee the needs of support for your team before they even realize it. We think you have the capability to zoom into details but also understand the bigger picture.

What we can offer

You will get an opportunity to work together with highly skilled colleagues in a fast-paced, cross-functional environment which provides opportunities to develop both professionally and personally. You will work in close collaboration with various stakeholders inside as well as outside of the company and you will be involved in many different types of projects. We encourage the will and courage to try new ideas, failure is not something we are afraid of, it’s something from which we learn and grow. Focus, integrity and courage; our company values which speak to our drive to appreciate and support each team member and to treat each other with respect and to maintain a high professional standard. We can give you the opportunity to set the tone in our team and to help us build and develop the business further.

About the role

With direct report to VP Regulatory Affairs and Quality Assurance you will manage multiple priorities all while maintaining a strong attention to details. You will be a key player in a fast-growing cross-functional team and work closely with VP Regulatory Affairs, Quality Assurance Manager, and other colleagues across the organization.

Main tasks

  • Assist in establishing, maintaining and organizing the required documentation and correspondence for new drug applications, variations/supplement submissions, clinical trial applications, protocol amendments and other filing activities to the FDA, EMA and other Health Authorities.

  • Filing and organizing various Quality Assurance documents.

  • Handling the QMS training system for Ascelia Pharma employees.

  • Coordinating with the project team to ensure timely delivery of submission documents.

  • Assists in a variety of complex administrative duties involving contact with global Health Authorities

  • Function as the company’s user support for the IT system used as document management system for regulatory documents, quality processes, training, and trial master files.

  • Scheduling and preparing for meetings as assigned, including agendas and supplemental documents.

  • Assisting with special projects and ad hoc day-to-day tasks.

  • Other duties as assigned.

Who are you?

You preferably have a university degree, and it would be a significant merit if you have:

  • experience from a pharmaceutical company or clinical research

  • regulatory submission experience

  • demonstrated competence in oral and written communication with focus on regulatory documents in English

We do see that you will need to have

  • a positive, friendly, and professional demeanor and must be organized and attentive to detail

  • flexibility with changing priorities and able to communicate in a diplomatic and professional manner

  • ability to exercise independent judgment in fast-paced, ambitious environment with strict deadlines

  • ability to manage multiple projects

  • considerable computer skills and experience from working with various computerized systems including Word, Excel and other Microsoft Office Software.

As a colleague and professional you

  • Build strong relationships with co-workers of various backgrounds and expertise

  • Enjoy providing support to other team members

  • Demonstrate ability to operate in a fast-growing cross-functional environment; experience in a start-up biotech company is a plus

  • Set ambitious goals and solve tasks in a collaborative manner

  • Are fluent in both spoken and written English and deliver effective written and oral communications to peers, management, and regulators

  • Show integrity and professionalism when handling sensitive information

  • Are excited about the Ascelia Pharma’s product portfolio and opportunities ahead

Other information

Work location: Preferably able to work primarily from the head office in Malmö with the possibility to work from home.

Domicile: Hyllie Boulevard, 215 32 Malmö, Sweden

Only candidates with work permit in Sweden will be considered.

How to apply

Please submit your resume and cover letter, along with any other material, on as soon as possible. All applications must be in English and are treated confidentially.

Candidates will be assessed as applications are received. Only candidates considered will be contacted.

For more details about the job or the company, please contact Marie Källström, VP Regulatory Affairs and Quality Assurance +46 (0)73 51 79 120.

Mer info
Område Malmö stad
Yrkesroll Teknik & Ingenjör
Typ av anställning Heltid
Sista ansökningsdag 31 mars 2023 (8 dagar kvar)