Location: New Jersey

Job Title: Associated Director Regulatory Affairs

Job Responsibilities:

• Formulate, lead and drive regulatory strategy for chemical and biological modalities to support clinical development in oncology and autoimmune disease areas from early development throughout product registration in the US and other countries

• Lead and drive Regulatory submission activities (planning, authoring, reviewing, coordination, submission) in support of Pre-IND, IND, NDA/BLA and other product life-cycle activities and Health Authority consultations

• Responsible for delivering high quality Regulatory dossier or other submission documents

• Lead Health Authority interactions for product development, including setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans

Qualifications and requirements:

Science degree (e.g. Chemistry, Biochemistry, Molecular Biology, Biotechnology, Biology, Pharmacy) or equivalent; advanced degree desired

• Minimum of 5 years’ experience in Regulatory Affairs and pharmaceutical clinical development; preferred experiences in oncology an autoimmune therapeutic area

• Extensive knowledge in FDA, EMA and ICH guidance/guidelines and expertise in regulatory submission and approval processes; ability to analyze complex regulatory issues and requirements

• Demonstrated successful experience in delivering Regulatory milestones in product development and registrations

• Experience of direct communications and negotiations with Regulatory agencies

• Demonstrated competence in leading functional team to support Regulatory activities and interface with CRO in related tasks

• Meticulous attention to detail and ability to follow procedures

• Candidate must be highly organized and capable of working independently