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Senior/Principal Regulatory Affairs Consultant

Parexel International Corporation

United Kingdom - Any Region - Home Based

We are now looking for a Principal or Senior Regulatory Affairs Consultant to join one of our exciting client dedicated project. In this role you will use your strong expertise in clinical development to support IND/NDA/BLA maintenance, support filings, support FDA meetings, support post marketing activities, representing regulatory at study team meetings, and coordinate answers to regulatory questions.

Role requirements: Knowledge and experience on European regulatory strategy for compounds from early development through to MAA approval and beyond. Experience in MRP, DCP and CP submissions and EMA/national scientific advice Support IND/NDA/BLA maintenance, support filings (INDs, BLAs, NDAs), support FDA meetings, support post marketing activities, representing regulatory at study team meetings, and coordinate answers to regulatory questions. Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Affairs-specific systems, processes, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant tools Completes other routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources Participates in other special projects, as and when assigned, or otherwise requested Remain, at all times, fully abreast and apprised of evolving internal and external needs, processes and requirements as appropriate. Expected to share best practices within the department and cross functionally, identify and communicate opportunities for departmental enhancements and efficiencies Consistently complies with all governing laws, regulations, SOPs and other guidelines QualificationsSkills and Experience required for the role:

• University Degree in a Scientific or Technical Discipline. PhD or other advanced degree (i.e. MBA) preferred

• 9 years + experience with expert level industry or regulatory knowledge; experience with a regulatory agency (such as FDA, MHRA) is a plus

• High-level consulting skills

• Critical thinking and problem-solving skills

• Project leadership and management knowledge

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Client-focused approach to work, results orientated

• Teamwork and collaboration skills

• Proficiency in local language and extensive working knowledge of the English language

Job posted: 2022-04-08

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