IWA Consulting seeks Specialists for Regulatory Affairs
Are you ready to take your career to the next level?
- By using your broad knowledge within Regulatory Affairs you take a vital role in helping our clients getting their products on market.
We are looking for colleagues to join our Regulatory & Medical Development Team
IWA Consulting has long term regulatory experience in the Pharmaceutical/Biotech and Medical Device Industry.
We assist Pharma and Biotech companies in achieving their major regulatory milestones, knowing and thoroughly understanding the sense of urgency that applies to this business area. Regulatory affairs – in every aspect of the discipline – is our core competence.
You will join a company that prides itself on our deep insight and thorough understanding of the regulatory field for Medicines, Medical Devices, and Combination Products.
Joining our team implies a unique opportunity to learn, develop professionally, and make good use of your knowledge in a vital role to our clients.
We work from the IWA Consulting offices either in Køge or in Copenhagen or at our clients’ offices where we work as part of their team of regulatory specialists.
At IWA Consulting we work together and help each other on how to approach the many challenges we meet in our daily work.
- Together, we have experience in every corner of the challenging field of Regulatory Affairs
- This is one of the reasons why we are the preferred partner to our many loyal clients
Working in our Regulatory & Medical Development Team
Being in charge of projects and clients, you will be planning your working hours and your place of work, in thorough cooperation with the rest of the R&M team and with the clients.
We support clients in a variety of different areas covering Medicinal products, Medical Devices, and Combination Products.
We have world wide experience within our Regulatory Affairs teams, both with regards to development projects as well as life-cycle management.
We will expect you to assist with several of the following tasks, depending on your experience and interests:
Product Information Management:
- SPCs, PILs and labelling in accordance with QRDs; Danish and English
- Assistance in NPs, MRPs, DCPs, CPs and variations with regard to:
- 3.1 preparation and updating in accordance with RMS/CMSs comments incl. response documents for 1.3.1
Development Medical and Regulatory Affairs writing:
- CCDS, IB, PIP, ODD, CTA etc.
- Review and approval of marketing material for Nordic countries
- Preparation of Abbreviated Prescribing Information for Nordic countries
- Review and handling of RMP documents in the Nordic countries
General Regulatory Affairs:
- Assistance in other IWA Consulting teams in general regulatory affairs support such as
- Post-approval regulatory activities
- Ad hoc assistance in other regulatory tasks
- Hold a Master of Science degree (MSc) or other relevant education
- 2+ years of experience within Regulatory and Medical Affairs
- A track record in World Wide product registration and project planning.
- Fluent in Danish and English at a professional level, both written and spoken
You are a person, who is driven by a high commitment to delivering results every time.
Being analytical and science-driven, you identify and resolve problems in a timely manner. You are a flexible and adaptable person with a hands-on attitude. You are pragmatic with an open and communicative approach, and have the ability to develop effective working relationships with customers at all levels. You are able to handle and deliver on routine jobs when necessary, while at the same time, have the ability to move projects forward.
IWA Consulting offers you an exciting and challenging position in a well-consolidated company with a short line of command and a high degree of flexibility in your everyday life.
You will work together with highly skilled and experienced colleagues to support our clients.
IWA consulting is based in Køge, 2 minutes from Ølby train station and at COBIS Science Park, Copenhagen. Our clients are mainly based in the Copenhagen area.
Read more about us at www.iwaconsulting.dk.
Please forward your application and CV to Lise-Lotte Ostermann: firstname.lastname@example.org as soon as possible.
If you need additional information about the position, please do not hesitate to call Head Regulatory & Medical Development, Lillan Rejkjær: email@example.com; +45 60151636.