Regulatory Affairs Manager coordinating regulatory submissions and compliance for Patient Assistance Programs in Brazil. Collaborating with stakeholders on program execution while ensuring ethical standards.
About the role
- Senior Regulatory Affairs Consultant at Parexel developing regulatory submission strategies for pharmaceutical products. Leading regulatory teams and managing multiple submissions in a fast-paced environment.
Responsibilities
- 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
- 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
- Monitor and stay abreast of key changes in the regulatory environment of international markets
- Coach, mentor and lead regulatory teams to ensure objectives are successfully delivered on time and with quality
Requirements
- 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
- Fluent English, written and spoken.
Benefits
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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