PAREXEL International LLC Regulatory Consultant - CMC in United States
Regulatory Consultant - CMC USA - Any Region - Home Based Date posted05/02/2021 Job ID68706BR
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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.
- Glassdoor Reviews and Company Rating
Check out the top traits we're looking for and see if you have the right mix.
"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
- Global Impact
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's Regulatory Consulting team continues to grow! We are currently looking for experienced CMC Regulatory Affairs professionals who are passionate about drug development and committed to making a difference!
This is truly a fantastic opportunity to join Parexel’s highly recognized Regulatory Consulting Services Team as a Consultant and work alongside some of the most respected Thought Leaders in the Industry!
As a CMC Consultant, you will be responsible for working with various clients:
Authoring high quality CMC documents including, regulatory authority requests for information, meeting briefing books, meeting minutes, IND/IMPD/CTA submissions, NDA/MAA/BLA submissions, and DMFs while assuring all documents meet regulatory requirements and quality compliance.
Preparing for Health Authority Meetings and attending these meetings as needed
Assisting in the preparation of responses to HA questions on pre and post-approval activities
Participating in strategic regulatory advice discussions with regards to pre- and post-marketing issues to clients
Conducting due diligence and gap analysis of existing products, and advising on remediation activities
Developing and maintaining excellent relationships with internal cross-functional groups and Parexel clients
As needed, the Consultant may be asked to provide Regulatory Affairs Generalist support to clients by providing assistance with insight into forms required and/or specific section requirements for HA submissions
The Consultant may be asked to serve as a US Agent for international clients
Qualifications Desirable Skills:
• High-level consulting skills
• Critical thinking and problem-solving skills
• Project leadership and management knowledge
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Client-focused approach to work
• Results orientation
• Teamwork and collaboration skills
Minimum of a Bachelor’s Degree, Advanced Degree preferable in Biochemistry, Biotechnology, Molecular- or Cell Biology, or have comparable experience in research
5-7+ years relevant experience in the pharmaceutical industry in roles such as Product Development, Manufacturing, Quality or Regulatory Affairs CMC with direct experience in authoring relevant sections of Heath Authority Applications to include INDs, NDAs, and/or BLAs.
Previous Regulatory CMC experience in small or large molecules and or vaccines or biologics with extensive experience in preparing documentation for regulatory authorities.
Demonstrated ability to author and deliver high quality regulatory documents. Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements, guidelines, and market and policy trends.
Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities.
Previous experience interacting with a regulatory agency (such as FDA, MHRA) is a plus
Knowledge of a variety of dosages forms is a plus.
Up to 30% domestic or international travel may be required in the future when travel restrictions are lifted and it is sage to do so
EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.