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Regulatory Affairs Consultant (CMC vaccines)
PAREXEL International Corporation
Regulatory Affairs Consultant (CMC vaccines)
Bucharest, București, Romania
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.
Glassdoor Reviews and Company Rating
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"When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."
Chris – Associate Director, Regulatory & Access
"In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"
Riley – Regulatory Affairs 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 Romania is currently seeking experienced CMC Regulatory professionals to join exciting projects for well-known pharma and biotech clients.
A Regulatory Affairs Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting provides. A Regulatory Affairs Consultant must have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Lead, a Consultant assures the work of the entire team is delivered on time and that it meets the client’s quality expectations.
We are currently looking for a Regulatory Affairs Consultant who will have the following responsibilities:
Key Responsibilities Collaborate with Global RA CMC lead and/or Regional RA CMC lead to provide regulatory support for assigned projects
Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA)
International registration of drugs related to the production sites / subsidiaries
Analysis of local requirements and adaptation of the contents of module 3 (US, EU, international)
Management of the requests of samples
Life Cycle Management for allocated products
Prepare and coordinate the review and approval of submission-ready documents
Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations
Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data
Strong organizational skills in order to maintain a high level of productivity, innovation, to ensure assignments are completed on-time with a high level of quality
Ability to work independently with minimal supervision as well as part of a team environment
Willingness to work collaboratively by incorporating diverse perspectives
Proven ability to manage multiple projects, identify and resolve regulatory issues
Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company
A/BS in scientific or technical discipline or advanced degree
At least 5 years of CMC/regulatory affairs experience
Experience preparing CMC sections of Modules 2.3 and 3 (INDs, NDAs, and supportive amendments and supplements is a plus)
Thorough understanding of change management processes and regulatory requirements
Strong problem solving and diplomacy skills
Excellent project management skills
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