Senior Regulatory Affairs Manager – Iberia

Senior Regulatory Affairs Manager – Iberia

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Job Title : Senior Regulatory Affairs Manager – Iberia

Location : Madrid (2 days on site, 3 days remote)

About ADVANZ PHARMA

ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing the specialty, hospital, and rare disease medicines they depend on.

Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.

Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.

ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.

We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.

What You’ll Do :

As the Senior Regulatory Affairs Manager for Iberia, you will take full ownership of regulatory activities across Spain and Portugal. You will manage the product portfolio which will include products undergoing new Marketing authorisation application as well as those in the post approval life cycle phase, acting as the key contact for regulatory authorities and internal stakeholders. Your role will be pivotal in ensuring compliance, supporting product launches, and providing local strategic regulatory guidance across the business.

Key responsibilities include :

• Keep an oversight of ongoing and planned regulatory activities and provide local regulatory intelligence and strategic inputs to New Products and Life Cycle Management teams
• Acting as the primary liaison with AEMPS and INFARMED, including leading scientific advice meetings and negotiations.
• Establish and maintain a good relationship with AEMPS and INFARMED.
• Role will involve exposure to Senior Management and requires an individual with a collaborative approach and the ability to link with and influence others.
• Regulatory strategy planning, risk analysis, advice on regulatory procedures involving the Iberian countries.
• Provide in-country local regulatory intelligence to wider business (including regulatory team) on new regulations / updates or by providing clarity on interpretation of existing or new regulations as required.
• Overseeing labelling, artwork reviews, local databases and promotional material compliance.
• Collaborating closely with Commercial, Quality, Pharmacovigilance, Supply Chain, and EU teams.
• Responsible for timely submission of OOS notifications and exemption applications.
• Manage external consultants to ensure timely and compliant regulatory support.
• Providing local regulatory intelligence and strategic advice for new product introductions and pipeline projects including local launch activities.
• Supporting health authority inspections and quality activities as needed.

About You

We are looking for a highly motivated individual passionate about making a meaningful difference to patients’ lives. For this role, you will also have the following :

Qualifications :

Experience & Competences :

Knowledge & Skills :

Personal Qualities :

Why ADVANZ PHARMA?

The success of any company is driven by its people, and we are no different.

At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.

Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing the specialty and hospital medicines they depend on.

As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you’ll be empowered to own your work, explore new possibilities and make things happen.

But there’s more to you – and us – than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles – we have an active ADVANZ PHARMA Women’s Network; almost 40% of our managers are women.

We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.

We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.

To join us on our exciting journey, Apply now!

ADVANZ PHARMA's Commitment to Equal Employment Opportunities :

Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated. ADVANZ PHARMA is committed to providing equal employment opportunities for all employees and prospective employees without regard to race, color, religion, sex, age, national origin, ancestry, sexual orientation, marital status, disability, or other protected classifications to the extent required by applicable laws. In all instances, the company will continue to comply with all local laws governing employment practices. In addition, the company will make reasonable accommodation for any applicant or employee with a disability, both during the application process and on the job, whenever possible.

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