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Job Title
Regulatory Affairs Consultant - CMC vaccines (multiple locations)
Company
PAREXEL International Corporation
Job Description
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Parexel.com
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Regulatory Affairs Consultant - CMC vaccines (multiple locations)
Bucharest, București, Romania
Date posted
03/15/2022
Job ID
77525BR
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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.
Full Time
Travel: Yes
Glassdoor Reviews and Company Rating
Success Profile
Check out the top traits we're looking for and see if you have the right mix.
Detail-Oriented
Proactive
Problem-Solver
Results-Driven
Organized
Multi-Tasker
"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
Rewards
Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Collaboration
Work with industry leaders and subject matter experts.
Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
Variety
Opportunities to work on multiple accounts – never boring!
Management
Strong management with depth of experience working for global health authorities.
Responsibilities
Parexel Romania is currently looking for an experienced CMC Regulatory professionals to join exciting projects for well-known pharma and biotech clients.
As a Regulatory Affairs Consultant
you will have an understanding of the organization’s consulting models and methodologies. You will have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. In this role, you will ensure the timely performance of work within a project scope to the quality expectations of PC and the client. You may be also serving as a Project Lead assuring the work of the entire team is delivered on time and that it meets the client’s quality expectations.
This role can be performed remotely and be based in Romania, Poland, Czech Republic, Hungary, Lithuania or Turkey.
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
Qualifications
Skills and Experience required for the role:
University degree in scientific or technical discipline
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
Fluent English both written and spoken
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'Corporate Equality Index' 2022
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