Vi søger erfaren Regulatory Affairs Manager – Stillingen er besat

Vi søger en erfaren Regulatory Affairs Manager, som hurtigt vil kunne arbejde selvstændigt med opgaverne. Ved du en masse om CTD, eCTD og mere specifikt om et eller flere af modulerne 1-3? Du skal indgå i et team med dygtige kollegaer. Vi tilbyder alsidige opgaver, en arbejdsplads med få møder og fleksible arbejdsforhold. Måske drømmer du om nedsat tid?  Kunne du tænke dig at arbejde hos os i Billev Pharma? Så kontakt os.

Our regulatory team

As of January 2020, Karen Jensen will hold the position as Head of Regulatory Affairs and Charlotte Munk Ejlersen now holds the position as Senior Regulatory Affairs Manager.

Karen and Charlotte, together with the rest of our regulatory team, achieve high quality output and have specialized qualifications within all fields of regulatory affairs.

On 30-31 January you have the opportunity to meet Karen in Amsterdam at the Regulatory Affairs conference arranged by Medicines for Europe.

Poor-quality translations may delay your time to market

Maria Brogaard is our state-authorised translator who has been with us for more than 15 years. Maria provides high-standard translations and proofreading of product information and all other documents in connection with regulatory procedures and pharmacovigilance in an environment where deadlines are often extremely tight. Her work receives extraordinarily positive acknowledgement from the health authorities.

Maria is a qualified user of the SDL Trados Studio and efficiently handles complex translation projects. It goes without saying that all her translations are performed in compliance with QRD templates and national guidelines. Also, research of background sources and the four-eyes principle are vital elements of the translation process.

Some of our clients previously used other translation services which in the short run may be less expensive. They turn to Maria because of her high-grade translations as they have realised that poor-quality translations and non-conformity with templates and guidelines delay the entire procedure and the time to market.

Maria is one of the most experienced and most talented translators within her field – we are lucky to have her in our team.

You can read more about Maria’s qualifications on our website

We now cover all areas within regulatory affairs

In February 2019 Susanne Thiilborg, Ph.D.Pharm., began a position as Regulatory Affairs Manager with Billev Pharma. Susanne has more than 20 years’ experience within analytical chemistry from the pharmaceutical company Lundbeck.

Susanne accounts for all possibilities and reviews the relevant issue from all aspects before drawing a conclusion.

With her extensive experience Susanne can help you with writing and reviewing the regulatory documentation for clinical trials (IMPD, IND), initial MAA/NDAs or maintenance activities such as variation applications. Also, she is able to assist you with compliance projects identifying and cleaning up GAPs in your quality documentation.

We are happy that Susanne has joined our company. With Susanne on our regulatory team we now cover all areas within regulatory affairs.

You can read more about Susanne’s qualifications on our website

We started 2019 by welcoming 3 new employees in our Billev Pharma team

Trine Lorentzen, M.Sc. Pharm., filled the recently established post as QA Manager. Trine has several years of solid experience with Good Distribution Practice (GDP) and the function as Responsible Person.

Are you facing an inspection? Are you struggling to keep your QMS up to date? Are you lacking the capacity or qualifications to audit you contract takers or suppliers? Would you like to have an external expert opinion during your self-inspection or audit?

Trine can determine the GAPs in your QMS and help you close them. 

Trine has hosted many inspections with impressive results. She is an experienced GDP Lead auditor and conducts her host function in a pleasant and constructive tone with a flash of humour.

You can read more about Trine’s qualifications on our website

Could you use a helping hand in your regulatory department, or do you lack the specialised staff in-house to handle European procedures?

In June 2018 Karen Jensen, M.Sc. Pharm., joined our regulatory team. Karen and our regulatory team can assist you with both European and national initial MAAs or maintenance activities.

Karen is a generous co-worker and has more than 16 years of experience working as Special Adviser with the Danish Medicines Agency. She has a flair for quickly identifying the heart of the matter and for problem solving. Karen has excellent communication skills, also when it comes to extremely specialized topics, and it goes without saying that she strives to meet the deadline. Karen joining our team has indeed strengthened our knowledge within regulatory affairs. You can read more about Karen’s qualifications here

Anniversaries in 2018

In 2018 we celebrated Billev Pharma’s 40 years anniversary and also 3 times 10th anniversaries.

Mette Skaarup Pedersen has been with us since 2008. Mette’s key area is proofreading and translation. Mette is highly respected among our clients for her eye for details – she is always willing to give a helping hand and a friendly smile.

We have also been with Billev Pharma for 10 years. We are proud to witness the expansion of the Billev Pharma team while aiming at providing our clients with useful and reliable support within the fields of regulatory affairs, pharmacovigilance and quality.

Anja and Ulrikke, Directors and Owners of Billev Pharma ApS