Regulatory Affairs Specialist
About The Position
Due to ongoing global expansion, Innovaderm is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for overseeing global central Ethics Committee (EC), Regulatory Authority (RA), and other submissions created within or outside of the company to ensure submissions comply with applicable regulations and guidance documents and contractual timelines are met. You will provide leadership for assigned projects regarding all activities that lead to start up of clinical trials.
- Coordination of regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions. Includes oversight of EU (mainly), APAC, and North America submissions.
- Review of regulatory documents and submissions created outside of the company by subcontractors (eg, partner CROs, regulatory vendors) to ensure high quality standards before submission to RA / EC
- Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards
- Point of contact for Sponsors and subcontractors/local teams for all aspects related to study regulatory submissions
- Preparation or review of country specific Patient Information Sheet/Informed Consent form documents.
- Preparation or review of study-specific templates of regulatory forms.
- Manages translation requests with vendor.
- Regulatory support and advice to local project teams and key internal/external customers; provide project specific local EU submission strategy and technical expertise
- Maintain high level knowledge about EU and non-EU regulations in the area of company interest
- Participation in Kick-off meetings, audits, and other project related meetings according to the company / client needs
- Bachelor's degree (or equivalent) in a scientific discipline
- Minimum of 2-3 years of clinical research experience (in CRO or Pharma) working within EU regulatory affairs is required
- Experience in study start-up is essential
- Hands-on experience preparing, reviewing, and submitting regulatory documentations
Knowledge and skills
- Excellent knowledge of applicable EU regional / national country regulatory guidelines and EC regulations (such as Poland, Spain, Germany, France, Georgia)
- Excellent knowledge of GCP and ICH standards
- Fluency in English with excellent oral and written skills, required
- Additional languages represent an asset
- Excellent organization and communication skills, great attention to detail
- 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;
The work environment
At Innovaderm, you will work with brilliant and driven professionals. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
As a Regulatory Affairs Specialist you will be eligible for the following perks:
- Permanent full-time position
- Flexible schedule
- Home-based position
- Ongoing learning and development
Innovaderm is a contract research organization (CRO) specialized in dermatology. 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, Innovaderm continues to grow and expand in North America and Europe.
Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Innovaderm only accepts applicants who can legally work in Poland.