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
- Level: Mid
- Travel: Yes
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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
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
Parexel Consulting is seeking a talented and experienced CMC Regulatory Affairs Professional to join our team as a Regulatory Affairs Consultant. In this role, you will have the opportunity to utilize your expertise in CMC, exceptional communication skills, and strong writing experience, contributing to our clients' success in the pharmaceutical industry. This position offers exposure to novel technologies and a wide range of responsibilities, from clinical trials to post approval and maintenance.
As the Regulatory Affairs Consultant, you will collaborate closely with a multinational pharmaceutical company, ensuring the effective planning, review, and preparation of CMC components for investigational new drugs, new drug license applications, progress reports, amendments, supplemental applications, and maintenance of approved marketed products.
This role can be home or office based in various Eruopean locations.
Your key responsibilities will include:
Assisting in the technical review and preparation of investigational drug applications, marketing applications, and other reports for submission to regulatory agencies.
Ensuring that documents meet established regulatory requirements in terms of content and structure.
Serving as a liaison between various functional groups, program teams, international regulatory bodies, and business partners, proposing solutions based on your technical experience and identifying potential project timeline delays.
Maintaining Regulatory CMC documentation.
Managing related databases and submission schedules.
Assisting in the development of submission plans and project timelines.
Preparing for and interacting with regulatory agencies during drug submissions, responding to inquiries, and participating in regulatory agency inspections.
Skills and Experience required for the role:
University degree in a scientific field
At least 5 years of relevant experience in the pharmaceutical industry or a regulatory authority
Successful experience in delivering CMC sections of marketing authorizations, investigational drugs, and life cycle management of commercial products.
Knowledge of EMA guidance, regulations, and ICH/GMP requirements.
Previous regulatory experience with small molecule
Experience with EU submissions via the Centralised Procedure and national procedures.
Experience with extension applications for new strengths and/or pharmaceutical dosage forms.
Experience supporting the preparation of CMC documentation for IMPDs and new product EU MAAs would be advantageous.
Ability to work independently and within project teams or committees, demonstrating accountability in achieving group goals and key project milestones.
Fluent in English written and spoken
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