Regulatory Affairs Manager

Hiring By - Biostaffic



Job Highlights

Not Disclosed

Posted 4 months ago
Job details

Regulatory Affairs Manager

Role: Full Time, Permanent

Location: Barcelona

The Role

We have a great opportunity for a Regulatory Affairs Manager to join our team, reporting to the Associate Director Regulatory Affairs and PhV, the role has primary responsibility for supporting activities within local regulatory affairs workflow including local regulatory pre-approval work until product launch, coordination and revision of variations, product information datasheets, as well as revision and follow-up of PSRUSs and addendum to Clinical overview. In addition, there will be opportunity to support of with PhV activities.

The Person

  • Knowledge of pharmaceutical law and the required documentation for pharmaceutical product
  • Experience on similar position in RA Department in a pharmaceutical company
  • Higher education; pharmacy, bioscience or relevant field
  • Fluent in English, both written and spoken is essential
  • Strong analytical and problem solving skills
  • Excellent interpersonal and communication skills
  • Flexible, with high levels of planning organization
  • Knowledge of MS Office, especially Excel

The Rewards

In return, we offer a competitive salary and rewards package (including holiday, bonus and pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach.

How to Apply

If you possess the experience, passion and ability to make this role a success then we would like to hear from you. Please complete your Candidate Profile on our careers site to apply for this role. The closing date is 14th March 2024. For more information, you can contact us on:

A Bit About Us

Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide.

To continue our growth, we’re looking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do, we offer rewarding opportunities for those looking for continued personal and professional growth, investing in training and development tailored to each individual’s focus. So, if you’re looking for an inclusive company to take your career to the next level, you’re certainly in the right place; come and join us to make it better.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • Spain

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
Accord Healthcare
Accord Healthcare

Current Openings: 0

Accord Healthcare is an award-winning pharmaceutical company driven to thinking differently so that more patients around the world have access to the essential and affordable medicines that they need. With operations in over 85 countries worldwide, and a pan-European footprint of more than 45 countries, Accord Healthcare develops, manufactures and distributes affordable medicines, and has one of the most active launch programmes in the European pharmaceutical sector. Life at Accord Healthcare is fast-paced and agile. We drive for results and are committed to delivering the highest possible standards because we understand that everything we do has an impact for our customers and for the patients that receive our medicines. We always strive to make it better by challenging ourselves to think differently and to deliver more every day. Whether it is product development, improving our systems and operations or building patient-focused added value services, we realise that each innovation could improve the lives of the patients who receive our medication. Living our purpose and achieving our goals means we can deliver more vital, affordable medicines to national health systems and the patients who need them most. At Accord we recognise that developing the skills and capabilities of our people is essential to the achievement of our organisation goals and we support each and every employee in doing so.
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