Global Regulatory Operations | eCTD Submissions | Regulatory Systems

Pharmacosmos is seeking an experienced Regulatory Affairs Coordinator to join our Regulatory Affairs department of 21 employees. The department manages new marketing authorisation applications and the life-cycle management of human and veterinary medicinal products globally.

The role supports global regulatory operations, including eCTD submissions, regulatory publishing, document management and life-cycle activities across international markets. Experience with Veeva RIMS is preferred and may provide the opportunity to take on implementation and post-implementation responsibilities, depending on the candidate’s background.

Your responsibilities

Supporting global regulatory operations, including submission planning, document handling and regulatory follow-up
Contributing to Veeva RIMS implementation, maintenance, user support and continuous improvement, where relevant to your experience
Preparing, compiling, technically validating and submitting regulatory dossiers in eCTD format across global markets
Ensuring submission readiness, document quality and high-quality regulatory data
Supporting product roll-out and life-cycle management of marketing authorisations worldwide
Collaborating with international affiliates and partners to prepare, compile and deliver regulatory documentation packages, ensuring timely submission and follow-up of variation and other life-cycle activities

Who are you?
We imagine that you:

Hold a relevant educational background within life sciences or a related field, combined with experience in regulatory affairs and pharmaceutical document handling
Have hands-on experience with Veeva RIMS, preferably including implementation, key user activities or user training
Have strong experience with the preparation, validation and submission of eCTD dossiers globally, preferably using Veeva Submission Publishing
Have experience with regulatory publishing, submission management and document processes
Have experience with broader regulatory activities, partner contact and international life-cycle management
Hold a relevant educational background and have experience from the pharmaceutical industry
Have strong IT skills and an interest in data quality, digitalisation and process improvement

Personal qualifications

You are meticulous, systematic and detail-oriented
You are proactive, take ownership and communicate effectively with internal and external stakeholders
You are curious, service-minded and contribute positively to a professional and social team environment
You are fluent in written and spoken English; Danish is considered an advantage
You thrive in a collaborative and international environment where quality and deadlines are important

We offer you
You will join a well-established global company and play an important part in supporting regulatory operations and strengthening our eCTD submission capabilities. Depending on your experience, you may also contribute to the implementation and ongoing development of Veeva RIMS. The role offers independent responsibility, close collaboration and exposure to global regulatory activities. Employment terms are negotiated individually based on your qualifications.

The position is located in Holbæk, with a minimum requirement of working in the office three days a week after completion of training.

Application
If this sounds like the right opportunity for you, we look forward to receiving your CV and cover letter.
For questions about the position, please contact Birgitte Møller, Senior Manager of Regulatory Operations, at +45 41 64 46 65.
Submit your CV and cover letter via the “Apply” button. Application deadline: 24 October.

About Pharmacosmos
Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 650 specialists across the UK, Ireland, the Nordics, Germany, Canada, and the USA.

About the company

Pharmacosmos focuses on developing and manufacturing pharmaceutical products and active pharmaceutical ingredients specifically for iron deficiency. Its offerings include iron-related therapies designed to treat iron deficiency in patients worldwide. The company operates by researching iron deficiency, ensuring product safety and efficacy, and distributing its products across multiple countries through partnerships and a wide distribution network. What sets Pharmacosmos apart from competitors is its long-standing family ownership, commitment to core values, and strong emphasis on research and quality, which support global expansion and collaborations to reach patients in need. The company's goal is to provide effective, safe iron deficiency treatments and improve access to these therapies for people around the world.

Company Size

201-500

Company Stage

N/A

Total Funding

N/A

Headquarters

Holbæk, Denmark

Founded

1965

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Company News

Webindia123

Jul 21st, 2026

Menarini Asia-Pacific and Pharmacosmos partner to bring first-in-class oncology supportive care therapy Cosela to Asian patients

Menarini Asia-Pacific and Pharmacosmos partner to bring first-in-class oncology supportive care therapy Cosela to Asian patients | NEWS HOME " BUSINESS Menarini Asia-Pacific and Pharmacosmos partner to bring first-in-class oncology supportive care therapy Cosela to Asian patients | / | COMMENT | | July 21, 2026 10:56:42 AM IST | PRNewswire Singapore, July 21: Menarini Asia-Pacific today announced an exclusive partnership with Pharmacosmos A/S to register, commercialise and distribute Cosela (trilaciclib) across its Asia-Pacific markets. Chemotherapy-induced myelosuppression (CIM) is a potentially debilitating side effect that damages bone marrow, significantly impacting its hematopoietic function (or its ability to produce healthy blood cells). For patients with extensive-stage small cell lung cancer (ES-SCLC), chemotherapy remains a cornerstone of treatment, yet it is a major dose limiting complication that can disrupt treatment and compromise outcomes[1]. Cosela is a first-in-class prophylactic therapy[2] FDA approved to help protect bone marrow from CIM, addressing a significant unmet need in oncology supportive care for these patients. Under the agreement, Menarini Asia-Pacific will manage all aspects of registration, reimbursement, commercialisation and distribution of Cosela in Australia, Hong Kong/Macau, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam. "Cosela represents an important advancement in oncology supportive care and the kind of innovation that can make a meaningful difference for patients," said Glen Godresse, Chief Executive Officer of Menarini Asia-Pacific. "Partnerships like this are central to Menarini Asia-Pacific's mission of helping innovative therapies reach patients with our end-to-end capabilities. We look forward to working with Pharmacosmos to expand access to Cosela across our region and help more patients benefit from this first-in-class treatment." "As we looked to expand access to Cosela across Asia-Pacific, we wanted a long-term partner with the capabilities to support every stage of the journey, from registration through to commercialization and patient access," said Klaus Abel, Vice President, Global Commercial Partnerships, Pharmacosmos. "Menarini Asia-Pacific's deep local market expertise and patient-focused approach make them the ideal partner to bring this important innovation to patients across the region." Cosela is currently marketed in the United States and China and is under registration in Europe. Subject to regulatory approvals, the first Asia-Pacific launch is anticipated in Hong Kong in 2028, followed by other markets thereafter. The partnership builds on an existing relationship between the two companies, following a 2024 agreement to commercialise innovative iron infusion Monofer across key Asia-Pacific markets. References [1]. Weiss JM et al. Managing Chemotherapy-Induced Myelosuppression with Trilaciclib. Clin Lung Cancer. 2021. Available at: https://pubmed.ncbi.nlm.nih.gov/33895103/ [2]. Alqahtani S, Alzahrani A, Alhakamy NA, et al. Trilaciclib: a first-in-class CDK4/6 inhibitor with dual roles in myelopreservation and cell cycle regulation. Medicinal Chemistry Research. 2024. Available at: https://link.springer.com/article/10.1007/s00044-024-03288-y This press release is intended for media and investor relations purposes only and does not constitute medical advice, product promotion or a recommendation for the use of any medicinal product. Cosela (trilaciclib) is subject to local regulatory approvals. About Menarini Asia-Pacific Menarini Asia-Pacific is a member of the Menarini Group, a leading international pharmaceutical and diagnostic company with a heritage of over 135 years and over 17,000 employees in 140 countries. Here in Asia-Pacific, Menarini's vision is to be a leading provider of important healthcare brands to improve the lives of people. Menarini Asia-Pacific operates across the entire commercial value chain, from clinical development, regulatory approval, and product launch to lifecycle management with a diverse portfolio of proprietary and partnered brands in key therapeutic fields, including Consumer Health, Dermatology, Allergy/Respiratory, Gastroenterology, Cardio-metabolic, Oncology/Specialty Care and Men's Health. (ADVERTORIAL DISCLAIMER: The above press release has been provided by PRNewswire. 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MedWatch

Jul 1st, 2026

Pharmacosmos hunts for acquisitions amid continued growth trajectory.

Pharmacosmos hunts for acquisitions amid continued growth trajectory. One of the country's wealthiest families is behind Pharmacosmos, which has achieved revenue of DKK 3.8bn. The next step is to surpass DKK 4bn. 1 July 2026at 10:45 Danish family-owned pharmaceutical company Pharmacosmos, which focuses on iron deficiency, has been keeping its foot on the gas. Try MedWatch for 14 days - and get access to all content. * Continues as a recurring subscription and is billed annually. Can be terminated after 5 months of subscription with 1 month's notice at the end of a month. Minimum price is up to €539.58 excl. VAT corresponding to 7 months of subscription. Right of withdrawal under the Consumer Contracts Act. Read more here. ** Continues as a recurring subscription for 3 months at a time. Minimum price €286.00 excl. VAT. Can be terminated with 1 month's notice at the end of a 3-month period. Right of withdrawal under the Consumer Contracts Act. Read more here.

Benzinga

Apr 8th, 2026

Incyclix Bio raises additional $5M in Series B to advance CDK2 inhibitor trial for breast and ovarian cancer

Incyclix Bio has raised an additional $5 million in its Series B financing round from Hatteras, bringing new support to advance its clinical trial of INX-315. The novel CDK2 inhibitor targets patients with CDK4/6 inhibitor-resistant ER+/HER2- breast cancer or CCNE1-amplified solid tumours. The funding will support clinical development of INX-315 for treating advanced and metastatic breast and ovarian cancer. Hatteras joins existing Series B investors including Boxer Capital, RA Capital Management, Eshelman Ventures, Eli Lilly and Company, Pharmacosmos and Cape Fear BioCapital. The Phase 1/2 open-label dose-escalation and expansion trial of INX-315 is currently ongoing. Kseniya Simpson and Christy have joined Incyclix Bio's board following the investment.

Scientist Live

Dec 9th, 2025

New study finds trilaciclib may mitigate chemotherapy-induced TP53-mutant clonal hematopoiesis

New study finds trilaciclib may mitigate chemotherapy-induced TP53-mutant clonal hematopoiesis. Pharmacosmos Therapeutics presented new investigator-sponsored research at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition. The abstract, "CDK4/6 inhibition mitigates chemotherapy-induced expansion of TP53-mutant clonal hematopoiesis" (Abstract #8419), was featured during a Plenary Scientific Session on December 7. Led by investigators from Washington University in St. Louis and Memorial Sloan Kettering Cancer Centre, the study examined whether the intravenous CDK4/6 inhibitor trilaciclib can reduce the expansion of chemotherapy-associated TP53-mutant clonal hematopoiesis (CH), which is a risk factor for therapy-related myeloid neoplasms (tMN). Pharmacosmos Therapeutics provided trilaciclib and blood samples from clinical trials with trilaciclib for use in this study, but did not sponsor or conduct the research. The research revealed that across three placebo-controlled trials involving patients with small cell lung cancer (SCLC, metastatic triple-negative breast cancer (mTNBC), and metastatic colorectal cancer (mCRC), administration of trilaciclib before chemotherapy was associated with a significantly lower rate of TP-53-mutant CH clone expansion compared to placebo. Concomitant treatment with trilaciclib and carboplatin prevented the expansion of p53-mutant hematopoietic stem cells while preserving normal progenitor cells under cytotoxic stress in preclinical murine models. Kelly Bolton, principal investigator and senior author, from Washington University in St. Louis, said, "The first time that an approach has been identified to reducing expansion of TP53-mutant CH during therapy. The data generated regarding trilaciclib's role are emerging across multiple clinical contexts, consistently demonstrating a potential pattern of reduced TP53-mutant CH growth." Omar Abdel-Wahab, co-corresponding author from Memorial Sloan Kettering Cancer Centre, said, "Therapy related myeloid neoplasms are a very troubling complication of cancer therapy. There are currently very limited effective treatments when therapy-related myeloid neoplasms occur. We are very excited about this study, as the results provide the first clue about a strategy to prevent the development of therapy-related myeloid neoplasms."

GlobeNewswire

Aug 25th, 2025

Incyclix Bio Secures $11.25 Million Series B Extension to Advance the Phase 1/2 Clinical Trial of INX-315 in Patients with CDK4/6 Inhibitor Resistant ER+/HER2- Breast Cancer or CCNE1-Amplified Solid Tumors

Financing will enable the completion of the ongoing Phase 1/2 clinical trial of INX-315 in patients with recurrent advanced/metastatic cancer...

Pharmacosmos

Regulatory Affairs Coordinator - Multiple Teams

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