Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
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
Director of Regulatory Affairs leading drug product regulatory strategy and team management. Ensuring compliance and managing communication with FDA and regulatory bodies in a pharma environment.
Consultant for GMP compliance and quality assurance in Life Sciences. Engage in validation projects and assist in compliance documentation.
Senior Project Engineer focusing on GMP Compliance in the Life Sciences sector. Responsible for project planning, execution, and client communication in Mannheim, Germany.
Senior Consultant managing Compliance projects in the medical devices sector with a focus on Quality & Regulatory. Collaborating with a dynamic team in a leading GMP - expert company.
Regulatory CMC Manager supporting multi - product global regulatory CMC for products at Marketing Authorisation Application Stage. Focused on documentation preparation, submissions, and providing regulatory support.
Manage Vodafone's satellite communications policy and regulations while collaborating with teams. Engage in strategic initiatives and develop regulations to support satellite ambitions.
Compliance Analyst managing fraud prevention strategies and governance in Brazil's iGaming sector. Ensuring compliance with regulations and internal policies in a dynamic environment.
GRC Consultant implementing governance, risk, and compliance projects for cybersecurity at Redbelt Security. Evaluating processes and recommending improvements to enhance cybersecurity effectiveness.
Customs Compliance Engineer focusing on customs classification and supporting import/export activities at Universal Robots. Collaborating with teams in Denmark and maintaining classification codes.