Senior Regulatory Affairs Strategist (home or office based)
This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Spain, United Kingdom, Ireland, Czechia, Italy, Croatia, Serbia, Oregon (USA) When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is seeking an experienced Regulatory Affairs Professional to join our dynamic team as a Senior Regulatory Affairs Consultant. This strategic position requires a proactive and agile regulatory professional able to build strategy, drive execution, and address challenges involved in gaining market approvals across international regions. You will provide expert guidance to our clients and delivery teams while managing multiple projects in a fast-paced, results-oriented environment. The role can be home or office based in various European locations. Key Responsibilities: Strategic Leadership
- Develop comprehensive international regulatory submission strategies for a wide variety of products and projects including CTAs, MAAs and Lifecycle management.
- Provide strategic guidance to clients and delivery teams on requirements and submissions across international regions
- Support or act as Project Lead, working with local market Regulatory Affairs experts to optimize strategies for specific submissions
Submission Management
- Guide delivery teams in the creation and maintenance of international dossiers
- Drive and manage multiple regulatory submissions simultaneously
- Ensure effective regulatory representation in partnership with appropriate technical experts at health authority meetings
- Document discussions and agreements with regulatory authorities clearly and comprehensively
Regulatory Intelligence
- Monitor and stay abreast of key changes in the regulatory environment of international markets
- Create and perform regulatory intelligence surveys
- Provide objective assessment of intelligence data
- Communicate regulatory requirements and propose submission strategies to clients
Team Leadership
- Coach, mentor and lead regulatory teams to ensure objectives are successfully delivered on time and with quality
- Identify and mitigate risks with respect to international submissions
- Guide cross-functional team discussions and drive regulatory solutions
Skills and Experience required for the role:
- University degree in a relevant scientific discipline (e.g., Biomedical Sciences, Chemistry, Pharmaceutical Sciences)
- 10+ years of experience in the pharmaceutical/biotech industry, with substantial experience in Regulatory Affairs
- Broad background in pharmaceutical business and experience in several areas within regulatory affairs (e.g., Global, European, International, Marketing Company or health authority experience)
- Experience with biologics/vaccines/infectious diseases/oncology and rare diseases strongly preferred
- Leadership in managing regulatory agency negotiations and organizing Scientific Advice Meetings with health authorities
- Strong knowledge of CTD format and eCTD submission builds, including preparation of Modules 1-5 documents
- Experience with Clinical Trial Applications and regulations relating to clinical trials
- Strong influencing, negotiation, and relationship management skills
- Advanced problem-solving skills and drive to generate compliant regulatory solutions
- Fluent English, written and spoken
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