Legal Regulatory Specialist-I (BABE)
About the job
Do you have a strong connection to the startup ecosystem and are you an expert in health care startups accelerate their market entry? Do you love speeding up our uique idea of hBABE study in the pharma sector? Would you be excited to use your experience and skills from the startup world to develop the ways of working in large, established organizations? If so, we’d love to meet you!
Team Gencyst is currently running three projects. Team of experts at Gencyst, invented microneedle patch and offering surgery free treatment for nail fungal infection to help 01 billion people around the globe, who are suffering from nail infection. Another unique startup project is the provision of low-cost hybrid Bioavailability & Bioequivalence lab (hBABE) services at significantly high quality.
Gencyst is looking for a Legal Regulatory Specialist-I for BABE study to be part of our international startup project hBABE services, and problem-solving legal regulatory work with regulatory authorities of government officials. If you have experience in these areas and want to take on exciting challenges, this might be the job for you!
The skills and experience we’re looking
- University degree with BABE certification (Class-III level) in regulatory affairs of BABE laboratory.
- BABE lab study validation certificate class-III level in legal regulatory affair matters.
- Experience & knowledge in facilitating public-private collaborations.
- Experience in research activities in the field of Molecular Genetics and Medical Lab technology.
- Knowledge and understanding of Ligand Binding Assay (LBA) Method Validation, stability testing, and high-quality bioanalytical sample analysis as per FDA/ICH/EMA guidelines.
- Detailed understanding of BABE study process across Phases II-IV and ICH GCP.
- Knowledge of the Pharmaceutical ecosystem and key stakeholders.
- Ability to understand clinical protocols and associated study specifications.
- Detailed understanding of BABE start-up processes and validation of study chain documentation.
- Follow Good Laboratory Practices (GLP), Company Standard Operating Procedures (SOPs), and Sponsor Study protocols.
- Support business development and marketing activities, foster client relationships and help onboard new clients.
- Ability to manage external vendors to contract effectively.
- Strong organizational skills with ability to handle multiple tasks effectively.
- Strong written and verbal communication and interpersonal skills.
- Ability to manage multiple project budgets with increased complexity and value.
- Quality-driven in all managed activities.
- Good communicating, negotiating skills and problem-solving skills.
- Demonstrated ability to work independently as well as part of a team.
- You must be fluent in English, Finnish, Norwagian and fluency in Percian is also preferred.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Compensation And Benefits
- Competitive compensation commensurate with industry experience.
- Discretionary performance bonus and equity participation at year-end.
- Two weeks paid annual vacation.
- 401k match and healthcare coverage to eligible employees.
- Accelerated career progression with flexibility to expand role and grow into the next level.
What We Offer
- Complex, meaningful work in a fast-changing environment.
- Work-life balance, flexibility in different life situations, and a caring, diverse environment.
- End-to-end involvement, from sales to proposal to delivery to re-sales.
- Responsibility from Day One – everything from decision-making power to accountability for your actions.
- Positive real-world impact on individuals and society in a myriad of measurable ways.