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Senior/Regulatory Affairs Consultant-CMC - Small Molecule or Biologics

USA - Any Region - Home Based Date posted 10/14/2021 Job ID 74433BR

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.

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

Excellent opportunity for an experienced CMC Regulatory Affairs professional to bring your talent, excellent communication skills, strong writing experience, and CMC expertise to Parexel Consulting as a Senior / Regulatory Affairs Consultant! This is tremendous opportunity to gain exposure to novel technologies and gain tremendous exposure from clinical trials to post approval, to maintenance, and everything in between!

In this highly visible as a Senior / Regulatory Affairs Consultant role, you will partner closely with a large multinational pharmaceutical company to ensure successful planning, review and preparation of CMC (chemistry, manufacturing and control) components of investigational new drugs, new drug license applications and related progress reports, amendments, supplemental applications, and continued maintenance of approved marketed products.


Responsibilities:
1. Assist in the technical review and preparation of various investigational drug, marketing applications and other formal reports for submission to regulatory agencies
2. Ensure that the content and structure of documents meet established regulatory requirements
3. Liaise as CMC representative across functional groups, program teams, international regulatory groups and business partners, propose solutions at level of personal technical experience and identify issues that may delay project timelines
4. Maintain Regulatory CMC documentation
5. Maintain related databases and submission schedules
6. Assist in developing submission plans and project timelines
7. Assist in the preparation and interactions with regulatory agencies regarding drug submissions, responding to inquiries and during regulatory agency inspections

Qualifications

At least 7+ years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity, with at least 5+ years of relevant experience for a Senior Regulatory Affairs Consultant. At least 5+ years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity, with at least 2+ years of experience relevant experience for a Regulatory Affairs Consultant.

• Successful experience in delivering CMC sections of marketing authorizations, investigational drugs and LCM of commercial products
Previous small molecule investigational product experience to include past experience with oral solid dosage products (previous experience with sterile, topicals, semi-solid, or combination products is a plus!) OR previous biologic investigational product experience
• Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority.
• Knowledge of global guidance, regulations and ICH/GMP requirements. Previous experience with FDA applications and updates are required. Previous experience with EU applications is a plus!
• Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.
• Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
• Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.
• Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally.

This role may require <15% travel to client location in the future as needed

EEO Disclaimer

Parexel 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.

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