Regulatory Affairs Manager

Amgen; Breda; On-site; EUR 90,000 - 120,000; Full time

Job summary

Amgen Breda is seeking a Regulatory Affairs Manager to translate CMC regulatory requirements into practical plans and lead site-specific submissions. The role includes coordinating post-market changes and regulatory communications with global authorities.

You will drive change control, support inspections, and work with manufacturing, quality and regulatory teams. Fluency in English and Dutch and strong leadership are essential.

Qualifications

• Doctorate or Master’s degree with 3+ years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharma/Biotech.
• Bachelor’s degree with 5+ years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharma/Biotech.
• Educational background in Biology, Biotechnology, Microbiology or Chemistry.
• Experience managing change control and regulatory submissions.
• Strong oral and written communication in English and Dutch.

Responsibilities

• Support the development and implementation of regulatory strategies for site changes.
• Lead submission processes for site initiatives.
• Provide regulatory expertise for manufacturing-related projects.
• Collaborate with Regulatory Authorities and Global/International teams.
• Support regulatory authority inspections as required by Site Quality Compliance.
• Serve as RA-CMC representative on Cross Functional Teams.
• Lead or contribute to site regulatory components for global submissions.
• Support generation of facility and GMP documents for product registrations.

Skills

Leadership

Regulatory submissions

Change control

Cross-functional collaboration

Project management

English & Dutch communication

Education

Doctorate/Master's with 3+ years in QA/Regulatory

Bachelor's with 5+ years in QA/Regulatory

Biology/Biotechnology/Microbiology/Chemistry background

Job description

If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drive all that we do. It is key to becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us as:

REGULATORY AFFAIRS MANAGER

At Amgen Breda medicines are labelled, assembled,storedand eventually shipped to various countries worldwide. Every day more than 1000 people with42different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines.

What You Will Do

In this vital role you will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans.

The primary responsibilities of this role are to support the planning and execution of the site-specific aspects of the preparation of CMC sections for new marketing applications, and post-market supplements and preparation CMC sections of annual reports of minor changes for specific products.

You will also act as key Regulatory Affairs (RA)-CMC representative for managing change control, deviations and serve as the point of contact for communications with business partners and global regulatory authorities for requests related to the site.

Specific responsibilities include but are not limited to:

• Support the develop and implementation of regulatory strategies as they relate to changes at the site.
• Lead submission process for site initiatives
• Provide strategic expertise regarding regulatory requirements for manufacturing related projects.
• Collaborate with Regulatory Authorities as appropriate and in coordination with Global and International representatives.
• Support regulatory authority inspections as required by Site Quality Compliance.
• Serve as RA - CMC representative on Cross Functional Teams.
• Lead or collaborate in the creation site related regulatory components for global submissions.
• Support the generation of facility and GMP related documents to be used in product registrations activities.
• Review and approve regulatory documents.
• Review and assess the regulatory impact of proposed manufacturing related changes, deviations and other GMP related documents.
• Maintain facility related files.
• Develop and maintain regulatory awareness through meetings, conferences and regulatory contacts.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs Manager professional we seek is a strong leader with these qualifications.

• Doctorate degree / Master's degree and 3 years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharmaceutical/Biotech industry
• OR Bachelor's degree and at least 5 years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharmaceutical/Biotech industry
• Educational background in Biology, Biotechnology, Microbiology or Chemistry
• Experience managing change control and regulatory submissions
• Strong oral and written communication skills in English and Dutch
• Strong negotiating and leadership skills
• Experience managing project timelines is desirable
• Proficiency working with teams at different levels and company locations
• Able to operate in a fast paced, dynamic environment

What You Can Expect Of Us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Therefore, Amgen is regularly recognized as a Best PlaceToWork.

• Vast opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance.
• Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food.