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Employer Sponsored Job (Free to apply to)
PAREXEL International Corporation Job Title
Senior/Principal Regulatory Affairs Consultant (China RA Manager)

Company
PAREXEL International Corporation

Job Description
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Parexel.com
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Senior/Principal Regulatory Affairs Consultant (China RA Manager)
United Kingdom - Any Region - Home Based
Date posted
04/19/2022
Job ID
81781BR
Apply Now
Overview
Success Profile
Rewards
Responsibilities
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Recent Jobs
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
We are looking for a client dedicated Senior Regulatory Affairs Consultant (China RA Manager)
. The position can be based in UK or in UE.

Key responsibilities:
Lead China regulatory strategy development for R&D portfolio and marketed products LCM for assigned projects
Lead CTA & NDA/BLA filings, and CDE consultation preparation activities by working with the China Affiliate and/or CRO, providing supervision to CRO project responsible, to ensure timely Regulatory filings and response to HA queries
Represent RA and provide regulatory strategy input to support successful development and provide Regulatory expertise to local product and cross-functional teams
Establish strong relationships with key internal and external stakeholders from a local, regional and global perspective.
Qualifications
Skills and Experience required for the role:
University degree required, Life/Health Sciences preferred
More than 10 years in drug R&D field
5-8 years regulatory affair experience in a multinational pharmaceutical company (preferably innovator company).
In-depth knowledge of regulatory environment, regulations and guidelines. Experience in HA interactions and pharmaceutical product registration.
Experience of clinical trial applications and associated strategy
Strong leadership capability and ability to work under pressure.
Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization.
Proficiency in verbal and written English; good computer skill, good presentation skill.
Apply Now
FAQ: Hiring during COVID-19
Learn how we recruit the best minds in these unprecedented times.
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Our hiring process
Find out what to expect when applying to Parexel
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Meet Stephanie: Associate Director Regulatory & Access
Stephanie shares her story about her development within Parexel, and what it's like to work here.
Learn More
Flexible Work Arrangement
In-office, home-based or a mix? What’s your preference? We value the work-life balance of our employees, and as such Parexel is offering maximum flexibility to our employees wherever possible.
Learn More


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