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PPD

Regulatory Affairs Specialist - Regulatory Intelligence Policy & Advocacy (RIPA), Bulgaria

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.   

If you’re a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment — and help get life-changing therapies to patients faster. 

As a Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist you will have a crucial role supporting core Regulatory Intelligence Policy & Advocacy (RIPA) deliverables including gathering business-critical regulatory intelligence, taking a lead role in compiling and authoring regulatory intelligence newsletters (e.g. monthly Regulatory Intelligence Focus, quarterly GRiD, monthly AT Forum Newsletter), providing Regulatory Intelligence support for business development activities (e.g. daily from RA, PM & SIA to address RFPs/RFIs and preparation for Bid defence meetings), supporting management of Regulatory Affairs external exposure (marketing) activities and thought-leadership through managing & authoring Regulatory Insights blogs & articles and/or supporting authors prepping articles, as well as billable work such as standalone Regulatory Intelligence billable projects & US label review.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. 

Essential Functions:

  • Manages, supports and responds to ad hoc regulatory intelligence queries.
  • Takes lead role for authoring and compiling Regulatory Intelligence newsletters.
  • Supports management of Regulatory Affairs external exposure activities.
  • Supports Regulatory Intelligence compliance through QC reviews and follow-up with in-country associates.
  • Develops collaborative working relationships with in-country associates and project teams.
  • Maintains knowledge and understanding of SOPs and current regulatory guidelines.
  • Coordinates and manages client deliverables supporting regulatory compliance.
  • Performs day to day operational activities as requested by the line manager/function head.

Bachelor's degree or equivalent and relevant formal academic / vocational qualification  

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years). 

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 

Knowledge, Skills and Abilities:   

  • Good English language (written and oral) communication skills as well as local language where applicable 
  • Good attention to detail and quality as well as editorial/proofreading skills 
  • Good interpersonal skills to work effectively in a team environment 
  • Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies 
  • Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects 
  • Good negotiation skills 
  • Capable of working independently with direction and exercising independent judgment 
  • Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables 
  • Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management 
  • Basic understanding of medical terminology, statistical concepts, and guidelines 
  • Good analytical, investigative and problem-solving skills 
  • Capable of interpreting data 

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. 

 

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD  

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you. 

 

Apply Now

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