Regulatory Affairs Specialist

United States  /  Quality, Compliance, & Regulatory  /  Full Time


About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
 
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
 
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
 
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
The Regulatory Affairs Specialist will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
 
Requirements include:
Position Description:
We are now seeking a Regulatory Affairs Specialist to join our growing operations in North America. The Regulatory Affairs Specialist will be responsible for the following:
Provide regulatory strategy and tactical support for assigned projects.
Prepare and deliver high-quality regulatory submissions & submission management plans for global regulatory agencies including INDs, NDAs, 510(k)s, annual reports and variation applications
Potential to act as Official Correspondent to FDA with responsibility for filing of annual reports
Support the client in understanding the regulatory environment by serving as an advisor on FDA / EMA related guidelines.
Maintain current knowledge of regulations and guidance pertaining to changes to approved regulatory applications
Act as regulatory / technical representative on client projects, assess regulatory risk and manage regulatory issues.
Provide regulatory support to QA team during regulatory inspections
Support regulatory gap analysis assessments
Assess regulatory pathways for new products and product modifications
Assist in developing regulatory strategies and tactical plans for submissions to international regulatory bodies.
Ownership/ regulatory responsibility for a portfolio of products for nominated client and responsibility for close liaison with Management/ other key personnel of the relevant business unit in the definition of product strategies in line with time frames for approval.
Establish and maintain positive relationships with the FDA and other regulatory bodies as required
Work collaboratively with other department colleagues to share best practice and information
Support US / EU regulatory initiatives and issues as appropriate for the business.
 
Position Requirements
The successful candidate will have at least 5+ years’ experience in Regulatory Affairs in the Pharma industry.
Applicants must be self-motivated, have experience working across US or EU, and have a strong background within the Pharma/Bio-Pharma industries
CMC - specific regulatory knowledge & experience is essential
BS or MS in a relevant science or engineering field, or equivalent
Excellent oral and written communication skills
Excellent problem-solving skills
Customer-service focused.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required 
Able to work (paid) overtime 
Able to work in the US without sponsorship now or any time in the future
Must have been vaccinated or willing to be vaccinated for COVID-19 prior to starting employment 
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CAI BENEFITS

(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • Other Benefits Depending on Country