Pharmaceutical Affairs Manager
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Job Location:
Monthly Salary:
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
Are you a Pharmaceutical Affairs/Regulatory specialist looking to take the next step into a role with real responsibility and impact Do you want to ensure the quality and safety of medicines while working in a fast-growing global biotech company
Ascendis Pharma is a global fast-growing biopharmaceutical company driven by our core values: Patients Science and Passion. Through our TransCon technology platform we develop best-in-class therapies that address unmet medical needs within rare endocrinology and oncology. With headquarters in Denmark and offices across Europe and the United States we are committed to improving the lives of patients and families worldwide.
The Role
As Pharmaceutical Affairs Manager you will support and oversee Ascendis Pharmas pharmaceutical activities in Italy. You will ensure compliance with Italian and EU legislation while contributing to operational excellence across distribution quality management pharmacovigilance support and overall regulatory interactions with authorities. This is a great opportunity for an pharmaceutical professional ready to step into a role with statutory responsibilitywhile still developing and growing within a supportive international environment.
You will work closely with local cross-functional teams in Sales Market Access and Medical Affairs and global colleagues in Legal Quality Regulatory Affairs and Supply Chain. You will report to General Manager Italy could be work remotely while attending meetings in Milan (Italian Office) and Copenhagen and travel according to business needs to work with Partners and Vendors
Your responsibilities
Pharmaceutical Operations & Compliance
- Oversee key regulated pharmaceutical activities including distribution storage import/export promotion medical information and quality documentation.
- Ensure compliance with Italian pharmaceutical laws (e.g. DL 219/06) Farmindustria code and other local and EU regulations (GDP/GMP/GVP).
- Review and approve documentation related to pharmaceutical operations distribution and product handling.
- Ensure proper storage and transport conditions to maintain product integrity and patient safety.
- Ensure compliance with safety-feature requirements under the EU Falsified Medicines Directive (FMD).
- Support preparation and submission of regulatory documents such as variations and notifications.
Quality Management
- Support the implementation and continuous improvement of the local Quality Management System.
- Approve and follow up on SOPs quality procedures and training documentation.
- Participate in internal and external audits including preparation and corrective actions.
- Manage deviations complaints CAPAs and quality indicators.
- Contribute to supplier qualification and review of technical and quality agreements.
- Support annual product quality reviews and quality documentation activities.
Pharmacovigilance & Safety
- Support local pharmacovigilance compliance in collaboration with the global safety team.
- Report and follow up on quality and safety-related concerns as required by legislation.
Interaction with Authorities
- Act as the key point of contact for Italian authorities (AIFA).
- Ensure inspection readiness and support regulatory or quality inspections.
- Report quality defects falsified medicines and other safety-related issues according to Italy and EU regulations in collaboration with local vendors
Cross-functional collaboration
- Work closely with local (and Global) Medical Affairs Sales Regulatory Affairs Supply Chain and Quality.
- Provide guidance and support to internal teams on regulatory quality and compliance requirements.
Qualifications
- Degree in Pharmacy or equivalent (e.g. Medicinal Chemistry)
- Experience with AIFA interactions on different matters
- Minimum 2 years of experience in Regulatory Affairs including Quality Pharmacovigilance or Distribution within the pharmaceutical industry.
- Knowledge of Italian pharmaceutical law EU GDP/GMP/GVP standards and quality systems.
- Strong English communication skills.
Key Competencies
You are a responsible and structured professional who understands the importance of regulated activities and communicate clearly and work well across functions fostering collaboration with colleagues in different parts of the organization.
You bring strong ethical standards and sound professional judgment which enables you to handle statutory responsibilities with confidence.
You approach your work proactively and with great attention to detail ensuring accuracy in every task. You are motivated by learning and growth and you feel comfortable taking ownership while seeking guidance when needed. You thrive in a dynamic environment and are driven by contributing to a purpose-driven biotech company that aims to make a meaningful difference for patients.
Apply now
Interested candidates should submit their resume and a cover letter highlighting relevant experience and skills.
Applications will be evaluated when received so please apply as soon as possible.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a ... View more
