As part of PAREXEL Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of PAREXEL Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
Check out the top traits we're looking for and see if you have the right mix.
"They say if you are passionate about what you do, you will never work a day in your life. I can honestly say that this applies to me. I love what I do."Jasen - Consultant
"My experience so far with PAREXEL has been great! I had initially started at PAREXEL as an Independent Consultant but was then presented with a full time job opportunity to really become a part of this fascinating company. I have enjoyed the flexibility to be able to orchestrate a good work/life balance, as well as learn from so many experts in consulting arena and really have a hands-on role with every day bringing a new but exciting challenge."Aqip – Consultant
"I was offered an incredible opportunity to continue my career in regulatory affairs without relocating 1,000 miles away and making major life changes. PAREXEL is an innovative, growing company which offers much needed flexibility and opportunities for professional growth."Blaine – Consultant
"PAREXEL is a very large organization and holds a top position amongst the different companies engaged in the Consulting business. It can offer many opportunities for development and career progression. Also the diversity of projects can offer a great expansion of knowledge in many areas of the Regulatory Affairs arena. Last (but not least), PAREXEL offers a variety of rewards to the employees (bonus scheme, benefits etc)."Giannis – Consultant
"PAREXEL is a CRO that I had always inspired to join because of the variety of knowledge, experts, culture, flexibility and exposure to be client facing as well as to use my technical knowledge all under a professional and diligent environment. I believe it has provided me the right platform to grow both professionally and individually with the opportunities to present my views and to dialogue with colleagues and clients with all but positive outcomes."Aqip – Consultant
We are one truly global team working together to propel each client´s journey ahead faster.
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Work with industry leaders and subject matter experts.
The ability to innovate, ask “what if” and try new solutions without fear of failure.
Opportunities to work on multiple accounts – never boring!
Strong management with depth of experience working for global health authorities.
PAREXEL is currently looking for a German speaking Senior Regulatory Associate. The role can be based in multiple EMEA locations.
• Writing and/or reviewing of CTD documents or other regulatory documents
• Participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME
• Communication with Health Authorities, mainly in the DACH region
• Familiarity with German Regulatory Affairs, ideally including national submissions, life cycle maintenance, labelling and agency contact.
• Similar experience with Switzerland and/or Austria beneficial
• Several years of Regulatory Experience
• Advanced German language skills
• Experience with writing CTD documents, which may include CMC, nonclinical or clinical summaries (IND, NDA, BLA, MAA), safety reports (DSUR, PSUR), RMPs, orphan disease applications, pediatric investigational plans, CCDS, variations etc.
• Good project Management skills
• Proactive approach and excellent communication skills
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