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IQVIA™, known as The Human Data Science Company™, stands out in the healthcare sector by leveraging data and science to enhance patient outcomes. The company focuses on advancing healthcare through innovative solutions derived from comprehensive healthcare information, analytics, technology, and human ingenuity. A recent opening has emerged within their lifecycle management team for a Regulatory Affairs Manager who is proficient in the Russian language. This position is particularly notable as it is designed for remote work, specifically aimed at candidates based in Portugal.
The Regulatory Affairs Manager role is pivotal in supporting activities related to the Russian market, making the ability to communicate fluently in Russian a primary requirement. The nature of this role is individualized, suggesting a significant degree of autonomy and responsibility in managing tasks and projects independently. Candidates should typically have a professional background encompassing at least five years of relevant experience in post-approval regulatory affairs relevant to Russia.
The responsibilities expected from the Regulatory Affairs Manager are extensive and emphasize a combination of both technical expertise and project management capabilities. These responsibilities include:
Serving as the Regulatory Lead on complex projects, potentially engaging in technical writing or acting as a project manager under the guidance of senior colleagues.
Competently producing regulatory and technical documents with minimal oversight, showcasing proficiency in documentation practices.
Fostering robust relationships with customers and stakeholders, including conducting face-to-face meetings to discuss regulatory matters and present lessons learned.
Taking a proactive and flexible approach to problem-solving, facilitating the resolution of regulatory issues.
Overseeing detailed reviews and management of project budgets, which includes determining out-of-scope activities and ensuring proper revenue recognition.
Providing guidance and feedback to junior team members, which may encompass document quality assessment and training assistance.
Representing the company in client presentations for regulatory deliverables in collaboration with senior staff, either remotely or in-person.
Contributing to the writing and revision of standard operating procedures related to regulatory processes.
Administering meetings with Regulatory Agencies to navigate compliance and regulatory approvals effectively.
Candidates interested in the role must possess certain educational qualifications and skills. The fundamental qualifications include:
A Bachelor's or Master's Degree in Life Sciences or a related field.
A minimum of five years of relevant experience in lifecycle management regulatory affairs focusing on the Russian market.
Native or fluent proficiency in the Russian language, ideally at the C1 level or above.
In addition to the above, the following skills are deemed critical for success in this position:
An in-depth understanding of regulatory procedures, intelligence in Russia, and knowledge of Research and Development processes (including Chemistry, Manufacturing & Controls, and Clinical Development).
Demonstrable experience in project leadership and adaptability to changing environments, ensuring the ability to deliver work on time while upholding quality standards.
Strong software skills, inclusive of expertise in Microsoft Office and relevant publishing applications.
An ability to collaborate effectively with clients and regional heads to establish regulatory strategies tailored to specific projects.
While the job posting does not provide specific salary details, the essential qualifications and expectations suggest that candidates should anticipate a competitive compensation package commensurate to their experience and the responsibilities they will handle. Regulatory affairs positions in regulated sectors typically offer attractive salaries, often complemented by benefits and opportunities for professional growth within a leading global firm.
As a home-based position, this role enables the selected candidate to work remotely, providing flexibility in work arrangements. This setup aligns with IQVIA's progressive stance toward workplace culture, emphasizing diversity, inclusion, and belonging. The company is committed to fostering an environment where varied perspectives contribute to innovative healthcare solutions.
For job seekers aiming to step into the realm of regulatory affairs within a healthcare context, this Regulatory Affairs Manager position at IQVIA provides a compelling opportunity. With a strong emphasis on utilizing data and science to enhance patient outcomes and a firm commitment to fostering a diverse workforce, IQVIA represents a forward-thinking employer. This role not only offers a chance to engage meaningfully with the regulatory landscape of the Russian market but also promises the potential for impactful career progression.
This job offer was originally published on himalayas.app
This job offer summary has been generated using automated technology. While we strive for accuracy, it may not always fully capture the nuances and details of the original job posting. We recommend reviewing the complete job listing before making any decisions or applications.
