Pharmaceutical Affairs Manager at Ascendis Pharma

Madrid, Community of Madrid, Spain -

Full Time

Start Date

Immediate

Expiry Date

11 Apr, 26

Salary

0.0

Posted On

11 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmaceutical Affairs, Regulatory Affairs, Quality Management, Pharmacovigilance, Compliance, Documentation, Communication, Collaboration, Attention to Detail, Problem Solving, Ethical Standards, Statutory Responsibilities, Cross-Functional Teamwork, Local Compliance Regulations, Quality Systems, Audit Participation

Industry

Biotechnology Research

Description

Are you a Pharmaceutical Affairs/Regulatory/Quality 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 Pharma’s pharmaceutical activities in Spain and Portugal. You will ensure compliance with Spanish and Portuguese and EU legislation while contributing to operational excellence across quality management, pharmacovigilance support, distribution, as well as all regulatory interactions with authorities (including supporting quality and tender management needs). You will also have or develop sufficient knowledge of local compliance regulations and norms to give local guidance. This is a great opportunity for a pharmaceutical professional ready to step into a role with statutory responsibility—while still developing and growing within a supportive, international environment. You will work closely with local cross-functional teams in Sales, Market Access, Medical Affairs, and Finance as well as global colleagues in Legal, Quality, Regulatory Affairs, Supply Chain, Compliance, and Finance. You will report to the General Manager, Iberia and are expected to be in the Madrid office 3+ days per week (otherwise may work remotely). Your responsibilities Pharmaceutical Operations & Compliance Oversee key regulated activities including distribution, storage, import/export, promotion, medical information, and quality documentation. Support preparation and submission of regulatory documents such as variations and notifications. Support administrative efforts related to regulatory documentation (e.g., Certificado de Exclusividad). Ensure compliance with Spanish and Portuguese pharmaceutical laws 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 Quality Management Support the implementation and continuous improvement of a fit-for-purpose 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 Spanish and Portuguese authorities (e.g., AEMPS, Infarmed). 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, Legal, Quality, Regulatory Affairs, Supply Chain, Compliance, and Finance. 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 AEMPS interactions on variety of matters Minimum 2 years of experience in Regulatory Affairs, Quality, Pharmacovigilance, and/or Distribution within the pharmaceutical industry. Knowledge of Spanish 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, communicates clearly, and works 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.

Responsibilities

The Pharmaceutical Affairs Manager will oversee pharmaceutical activities in Spain and Portugal, ensuring compliance with local and EU regulations. This role includes managing quality documentation, regulatory submissions, and interactions with authorities.