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Regulatory Affairs Associate

  • Job reference: 928648
  • Location: Cambridge, Cambridgeshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 11/12/2019

Orion Group Sciences are looking for a Regulatory Affairs Associate for our multinational pharmaceutical client based in the Cambridgeshire area on an initial 12-month contract with the potential to extend.

Job Purpose
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Assists in developing procedures to ensure regulatory compliance.

Main Responsibilities of the role

  • To implement regulatory strategies & deliverables for marketed products in the defined Therapy Area for the EEMEA Area (including Israel, Serbia, Russia, CIS, Balkans). In alignment with the overarching global regulatory strategy and in collaboration with the RA personnel in the region
  • Develop regulatory strategies in collaboration with the Regional Leads and follow up with variation submission
  • Understanding of Extended Europe Region regulatory requirements for MAA submission
  • Effectively interact with the RA personnel in the affiliates and regional level
  • Maintain an active awareness of EU and EEMEA legislation and assess its impact on internal business and R&D programmes jointly with Regulatory Intelligence. Develop and execute strategies to respond to those
  • Provide Area input on local implications through participation in teams as needed (e.g., submission teams, labelling working group)
  • Ensure regulatory compliance within EEMEA for the assigned compounds/products
  • Implement and manage reference label update across extended Europe region in line with Company Policy/SOP and regional requirements

Desired Experience and Background of the successful candidate

  • 2 years of Regulatory Affair experience
  • Has knowledge of commonly-used concepts, practices, and procedures within a particular field
  • Relies on instructions and pre-established guidelines to perform the functions of the job
  • Works under immediate supervision. Typically reports to a supervisor or manager
  • Skills: experience in a regulated industry, science academia or clinical practice

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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