Job description

Regulatory Affairs Manager - Gothenburg

Would you like the opportunity to work in a pharmaceutical company? Do you have experience of working with end-to-end document and submission publishing? Then this might be the right role for you!

We are now seeking Regulatory Affairs Managers for one of our clients in Gothenburg to join their Regulatory Affairs Management team. Could you be the one?

This is a consulting assignment with Randstad Life Sciences. Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Responsibilities

What you’ll do

Working in the role as Regulatory Affairs Manager (RAM) you will contribute to regulatory submission strategy, identify submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. You will also have more focus on the operational side of regulatory affairs.

Responsibilities:

• Lead and/or contribute to the planning, preparation, and delivery of submissions of varying complexity throughout the product’s life cycle from either a global and/or regional perspective.

• Provide regulatory input/ expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including submission delivery strategy of all dossiers and all application types per market and/or region and review of documents, e.g., response documents, study protocols, periodic safety reports

• Support operational and compliance activities for assigned regulatory tasks

• Provide coaching, mentoring and knowledge sharing within the regulatory skill group

• Contribute to and lead process improvement

• Identify regulatory risks and propose mitigations to appropriate member of cross functional teams

Do you have the essential qualifications for these roles?

To be successful in this role, we believe that you have a University degree in science or a related field.

About randstad life sciences

Randstad Life Sciences is specialized in competencies within Life Science. As a consultant with us, you get a competitive salary, benefits, and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

Do you have knowledge within Regulatory Affairs and want to develop your skills further? Then apply now!

For more information: Please contact Katan Ali, [email protected]

Qualifications

Do you have the essential qualifications for these roles?

To be successful in this role, we believe that you have a University degree in science or a related field. If you have regulatory experience within the bio pharmaceutical industry or similar, this will be an advantage.

We believe that you possess good project management skills as well as leaderships skills and that you have excellent written and verbal communication skills. It`s desirable if you have previous experience in leading multi-disciplinary project teams.

If you are ready to invest in yourself and your regulatory career, then this is the right challenge for you.

About the company

Randstad AB