Regulatory Affairs Analyst
With email
To apply with email, click the green button. If the email app on your computer or device doesn't open, copy the email address under the button and paste it into your mailbox. Then, attach your CV and add text to submit your application.
Deadline: 18 May 2024
Employment term: Permanent
Category: Healthcare/Pharmaceutical
Job type: Full time
Location: Yerevan
Job description:
We seek an experienced and meticulous Regulatory compliance analyst to join our vibrant team. The ideal candidate will play a crucial role in ensuring our company's compliance with regulatory standards (GCP, GLP, etc) relevant to the biotech industry. This position is integral to our mission of maintaining the highest standards of quality and integrity in our research and development efforts.
/en/regulatory-affairs-analyst-4
Job responsibilities
- Regulatory Guidance: Identify the key regulatory requirements applicable to BostonGene's operations and projects. Provide expert advice and guidance on regulatory compliance matters.
- Gap Analysis: Conduct thorough analyses to identify regulatory compliance gaps within the company’s processes and systems. Develop and implement strategic plans to address identified gaps.
- Documentation Preparation: Prepare, review, and maintain critical regulatory documents, including Standard Operating Procedures (SOPs), policies, and guidelines to ensure compliance.
- Continuous Improvement: Monitor changes in regulatory requirements and industry best practices. Update internal policies and procedures accordingly to maintain compliance and improve operational efficiency.
- Collaboration: Work closely with the Regulatory Affairs team and various departments, including Quality Assurance, Research and Development, Clinical Team, etc, to ensure cohesive regulatory compliance efforts across the company.
Required qualifications
- Bachelor’s degree in Life Sciences, Medicine, or related field. Advanced degree preferred.
- Fluent in both English and Russian.
- Excellent written and verbal communication skills, with proficiency in creating clear and comprehensive documentation.
- Detail-oriented with a commitment to accuracy and quality.
- Strong analytical skills and willingness to proactively work with large amounts of regulatory data.
- Experience in preparing SOPs/articles/patents/reports/research protocols.
- Nice to have:
- Experience in regulatory affairs, compliance, or quality assurance within the biotechnology or pharmaceutical industry.
- Familiarity with regulatory requirements and guidelines such as those from the FDA, EMA, or other regulatory bodies.
- Experience in preparing and submitting documentation for regulatory approvals.
- Knowledge of NGS, bioinformatics, immunology, or oncogenesis.
- Publication record.
Required candidate level: Mid level
Additional information
- The office is located in Yerevan, within a 1-minute walk from the metro, and on-site snacks.
- Complete documentation and bureaucracy support on-site (bank accounts, residence permit, school contacts, etc.).
- Full-time position, permanent contract, flexible working hours, hybrid work.
- Competitive salary.
- Healthcare insurance, corporate plans for English language lessons, and gym.
- Versatile professional environment: bioinformatics, biologists, physicians, and software developers who united to save people’s lives.
Professional skills
Analytics and research
Soft skills
Positive attitude
Detail-oriented
Analytical skills
Special tag
Flexible hours
Share this job via your favorite social media channel.
About Company
BostonGene Corporation is pioneering the use of biomedical software for advanced patient analysis and personalized therapy decision making in the fight against cancer.
Our unique solution continuously aggregates the latest cancer research and clinical information from around the world. BostonGene’s unique solution performs sophisticated analytics to aid clinicians in their evaluation of viable treatment options for each patient’s individual genetics, tumor and tumor microenvironment, clinical characteristics, and disease profile.
BostonGene’s mission is to enable physicians to provide every patient with the highest probability of survival through optimal cancer treatments using advanced, personalized therapies via sophisticated analytics and integration of scientific and clinical knowledge.
Benefits
Contact details
Website http://www.bostongene.com/
Address: Barekamutyun Business Center, Yerevan, Armenia
We use cookies. 
+374 43 901 900 
