RA Capital

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 local 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, Compliance and Finance as well as global colleagues in Legal, Quality, Regulatory Affairs, Supply Chain 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

Support the Global Ascendis team with:

Regulatory

• Oversee key regulated activities including distribution, storage, import/export, promotional material, medical information, and quality documentation.
• Ensuring compliance with Spanish and Portuguese pharmaceutical laws and other local and EU regulations (GDP/GMP/GVP/MDR).
  - Review documentation related to pharmaceutical operations, distribution, and product handling.
• Support preparation and submission of local regulatory documents such as variations and notifications.
• If Submission of material for pre-approval to local authorities is needed ensure that it is done.
• Support administrative efforts related to regulatory documentation (e.g., Certificado de Exclusividad).

Quality Management

• Support the local implementation of the Ascendis Quality Management System.
• QA/compliance contact person of local affiliate towards the global QA team.
• Draft and review affiliate-specific documents (SOPs, Forms, letters, etc.).
• Coordinate, support with translations/local legislations in case of interaction with local health authority .
• Support handling of local deviations/CAPA.
• Support the global QA team regarding local requirements/legislations.
• Facilitate interaction with local health authority (written and oral communication, local regulatory inspection, translations).
• Support QA and Supply Chain with any quality issues that might arise at local LSP.
• Represent the Spanish and Portuguese affiliate in periodic affiliate GxP meetings led by global QA.
• Support special local processes, e.g., distribution of free medical samples.

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

• In support of the Global Ascendis teams act as the local point of contact for Spanish and Portuguese authorities (e.g., AEMPS, Infarmed).
• Ensure inspection readiness and support regulatory or quality inspections.

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. High willingness to learn and grow in the other areas
• 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.