Senior Regulatory Affairs Specialist-Romania
Description The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions. This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables within a country, region or globally. This role will also support the Associate Director Regulatory Affairs in special projects, process improvement initiatives, training of new employees and company initiatives. ## Responsabilities - Coordinates regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions. Lead global/multinational submissions of complex large clinical trials. - Addresses Sponsor queries related to regulatory and submission requirements. - Provides regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise. - Prepares/reviews core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance. - Peer review of documents and packages prepared by colleagues within regulatory team. - Develops/reviews Country ICFs. - Performs regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites. - Develops/reviews country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements. - Participates in Kick-off meetings, client audits, and other project related meetings according to the company / client needs - Act as a mentor to new or junior colleagues within regulatory team. Responsibilities could include helping in assigning work; coaching/training; providing instructions; developing tools and processes to help daily work; helping in maintaining high quality of work of regulatory/ethics submissions - Support Regulatory Country Intelligence activities Requirements - Bachelors' degree (or equivalent) in a scientific discipline. Regulatory Affairs is an asset - 3-5 years in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry; experience preparing and submitting IRB/IEC packages and /or Clinical Trial Applications - Strong understanding of global regulatory requirements and guidelines in assigned countries / regions. - Experience in global leadership role with a focus on regulatory regions such as Europe and APAC (Australia/New Zealand). Experience of the regulatory process under EU-CTR. - Fluency in English with excellent oral and written skills, required - Additional languages represent an asset - Attention to detail and accuracy in work - Ability to organize own work, prioritize different assignments, and work under pressure - Versatile and comfortable in a multitasking environment - Respect established timelines, expectations, priorities, and objectives - Good knowledge of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA), and Regulation (EU) No 536/2014. Our company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities. As a Senior Regulatory Affairs Specialist, you will be eligible for the following perks: - Flexible work schedule - Permanent full-time position - Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities) - Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Romania. Apply To This Job