Senior Regulatory Affairs Specialist

Sr Regulatory Affairs Specialist

Location: US Remote, or Raleigh/Durham NC

'At ICON, it's our people that set us apart'

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

We are looking for passionate, resilient, and inspiring individuals to join our team. As the Senior Regulatory Affairs Specialist, you will contribute to drug development, as part of the SRS (Strategic Regulatory Services) Regulatory Affairs team through provision of regulatory guidance and operational support to early drug development, agency interactions, clinical trial applications, marketing application and post approval activities.

The role

• As member of the Regulatory Affairs team, you will contribute to at least one of the following activities, working under established procedures and mainly under supervision, however with the ability to work independently for routine activities and submissions :
  • Preparation, compilation and submission of routine Regulatory submissions e.g. CTA /IND, Variations / lifecycle submissions, orphan designation or PIP
  • Contribute to more complex projects (early development, MAA/NDA, Post Marketing) contributing to (for example) review and compilation of documents for Scientific advice/variations/MAA, document product label review, translation requirements, fee requirements and payments, submission planning
  • Support Regulatory Intelligence
  • Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within SRS
  • Communicate /liaise with clients, regulatory agencies / competent authorities and/ or other regulatory or functional experts on designated regulatory activities as required
  • Support to more senior team members on more complex projects
  • Undertake all required tasks requested to meet departmental and project goals, as appropriate
  • Participate in regulatory and/or clinical trial project teams as required.
  • Responsible for timely and accurate completion of assigned projects and for timely identification of issues including the need for change orders.
  • Identify department process and procedure improvements and assist in implementation of continuous improvement measures to ensure department expertise and to meet department's goals.
  • Identify issues, proactively seek advice and address them in a timely manner, including development of preventative actions (as necessary under supervision)
  • Assist in review or update of existing department standard operating procedures
  • Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary
  • Maintain an accurate record of the time associated with each allocated activity and ensure compliance with all timekeeping and tracking systems

What you need

• A minimum of a Bachelor's degree or local equivalent
• Minimum of 3 - 5 years in Regulatory Affairs in the Pharmaceutical industry, FDA experience would be advantageous
• Ability to multi-task, & support various projects
• Be able to solve problems in pro-active and timely manner
• Encourages and initiates teamwork. Respects diversity, values the opinions of others. Leverages teams' strengths, empowers and delegates appropriately