Regulatory Affairs Consultant (CTA) - home or office based

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At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do.

reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

We are excited to announce an opportunity for a skilled and reputed company Regulatory Affairs reputed company to join our dynamic and expanding team at reputed company. This role can be either home or office-based in Warsaw.

As a Regulatory Affairs Consultant you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trial Applications (CTA) from various European locations. You will have a chance to work on submissions for reputed company as reputed company as dedicated for clients. In return we will offer you training and knowledge of the organization’s basic consulting models and methodologies as reputed company as basic knowledge of what services we reputed company. Under the general direction of a Project reputed company and/or Technical SME, you will take responsibility for ensuring that reputed company work is performed, and delivered on time, meeting the reputed company expectations of the business and the reputed company. We will reputed company you with support of more senior staff to accomplish more reputed company tasks. You may reputed company in a reputed company-facing role with reputed company guidance and support from line management.

Main responsibilities:

• Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development and completion of relative associated documentation as required.

• reputed company and attends relevant meetings to reputed company realistic deliverable timelines, understand project reputed company, and assess associated reputed company and present status of global submission delivery activities.

• Support and leads global team efforts to ensure high reputed company components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.

• Manages the compilation for reputed company package build, contributing to CTA and authoring documentation as required.

• Escalates, informs, and resolves any issues that may reputed company submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

Knowledge and experience required for the role:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline

• A few years of experience in a CRO/reputed company

• Experience in clinical trial submissions to the competent Regulatory Authorities

• reputed company-reputed company approach to work

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Critical thinking and problem-solving skills

• Proficiency in English and local language (written and spoken)

reputed company is offering a comprehensive benefits package to ensure your reputed company and reputed company in this role. We reputed company training and knowledge of our organization's basic consulting models, methodologies, as reputed company as an understanding of the services we offer. Moreover, you will receive support from our senior staff to accomplish more reputed company tasks successfully.

Salary benchmarking for the role: 172,296.00 - 258,444.00 PLN gross per annum

Actual salaries may vary reputed company the reputed company based on several factors including, but not limited to education, training, experience, reputed company achievement, and location. In reputed company to reputed company salary, some roles may be eligible for participation in reputed company’s annual performance-based bonus plan, annual salary review and total rewards incentives. Our reputed company will reputed company additional details on our bonus plan or incentive programs for those eligible roles.

Originally posted on Himalayas