Senior Regulatory Affairs Manager - International scope

A leading company in the pharmaceutical sector, renowned for its innovative approach to developing speciality products is looking for a Senior Regulatory Affairs Manager. With a strong commitment to professional growth, the organization provides its employees with opportunities to take on increased responsibilities and play an essential role in the company's expansion. Based in Amsterdam, Netherlands, this position offers a unique blend of international engagement across Europe, Asia, and Latin America, so you can be sure to enjoy varied and interesting work.

Benefits

In this role, you will enjoy:

* A chance to take on added responsibilities, especially in developing new applications for generics, allowing you to witness personal growth within the organization.

* An exciting and fast-paced work environment in the Branded department, where you will be integral to driving innovation and change.

* A hybrid working arrangement, allowing you to balance your professional and personal life by working three days from home.

Role Responsibilities

As a Senior RA Manager, your responsibilities will include:

* Leading the regulatory strategy for innovative pharmaceutical products, ensuring alignment with evolving international standards and practices.

* Collaborating with cross-functional teams to influence regulatory agencies positively and facilitate the timely preparation of Marketing Authorization Applications (MAA) and scientific advice.

* Engaging with diverse cultures and regulatory authorities across the broader regions of Europe, Asia, and Latin America, enhancing the company's global presence and operational capabilities.

Requirements

To excel in this position, you should possess:

* A scientific degree, ideally in pharmaceuticals, complemented by a strong background in EU regulatory affairs with a minimum of 8 years of experience.

* Demonstrated experience in regulatory affairs for branded, innovative pharmaceutical products, with familiarity with biologics being an added advantage.

* A strategic mindset and fluency in English; proficiency in another EU language will be viewed favourably.

If you are a dynamic professional with a positive outlook who sees challenges as opportunities, we invite you to apply and contribute to a company leading the way in pharmaceutical innovation. Don't miss out on what could be a great new role for you.