Regulatory Affairs Specialist

This is a remote position.

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multicultural team PSC Biotech® is passionate about bringing the best and brightest together to form something truly special. When you decide to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits that reward you but also be provided with the tools that will help you grow and learn.

At PSC Biotech® it s about more than just a job it s about your career and your future.

We are hiring an experienced and motivated Regulatory Affairs Specialist. This position requires a strong background and understanding of lifecycle management of commercial products supporting ongoing pediatric studies label revisions and annual report submissions.

• Perform change order reviews
  
• Completes PCNs (product change notices)
  
• Support daytoday regulatory activities
  
• Gate keeps regulatory policies and procedures to assure compliance
  
• Monitor and continuously improve regulatory process and product compliance
  
• Review quality and product documentation (DCR s labeling etc.) to ensure compliance with global regulatory agencies
  
• Record and complete incoming registration/reregistration documentation requests as appropriate
  
• Maintain technical files design dossiers and all regulatory documentation in compliance with the Medical Device Directive and the Code of Federal Regulations
  
• Assure all regulatory documentation being sent is accurate and in compliance with regulatory requirements and Company procedures
  
• Communicate with all Company departments as needed to fulfill job requirements
  

Requirements

• A minimum of a BA/BS in a scientific related field
  
• A minimum of 3 years experience Regulatory Affairs CMC in the biotech/pharmaceuticals industry
  
• Post Approval Experience
  
• Excellent writing communication and interpretive skills
  
• Quality System experience (FDA ISO etc.)
  
• Risk Management experience
  
• Proven experience with Health Authorities submissions and a working knowledge of FDA/EMA regulations
  
• Assessment of risks related to regulatory and development activities
  
• Computer literate; use of word processing spreadsheets
  

Benefits

Offering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happily and healthily.

• Medical Dental and Vision PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
  
• Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
  
• 401(k) and 401(k) matching.
  
• PTO Sick Time and Paid Holidays.
  
• Education Assistance.
  
• Pet Insurance.
  
• Discounted rate at Anytime and 24Hour Fitness.
  
• Financial Perks and Discounts.
  

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employersponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.