đ Location: Companyâs office in Belgrade
đŻ Who we are?
Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patientsâ lives.
Optimapharmâ s key priorities are the well-being of our people, consistent quality delivery to our clients and healthy, sustainable growth.
With 26 strategically located offices, Optimapharm operates in 40+ countries, providing most optimal access to Patients and Investigators globally. Established nearly 20 years ago, we leverage our experience, stable project teams and collaborative, and flexible approach to secure a high level of repeat business, gain the trust of new customers and secure continued growth of the company.
Join our team as a Regulatory & Start-Up Manager in Belgrade and make a real impact on projects that benefit patients and their families worldwide. This role includes line management responsibilities, where you will lead, mentor, and support a team to achieve excellence in regulatory and start-up activities.
If you're ready to combine your expertise and leadership skills to drive meaningful outcomes, weâd love to hear from you!
đ What do we offer?
- Working in a successful company thatâs growing and changing every day
- Working with a highly experienced team of clinical research professionals
- International projects and professional growth
- Performance & referral bonuses
- Additional health insurance
- Flexible work hours
- Work from home days
- Training opportunities
- Meal voucher
- Multisport card
- Public transport allowance
đ Who are we looking for?
Qualifications and Experience
- University degree, preferably in medical or life sciences
- Minimum of 3 years experience in a regulatory and start-up function or other relevant experience
- Excellent knowledge of GCP and ICH Guidelines required for clinical trial conduct, ISO 14155, MEDDEV/MDCG guidelines concerning clinical investigations
- Must demonstrate a sound understanding of the drug development process and executing a project
- Excellent knowledge of regulatory requirements (international and local)
- Excellent interpersonal, written, oral and administrative skills
- Excellent organizational skills
- Ability to work in a fast-paced, team-oriented environment
- Excellent leadership and mentoring skills
- Excellent verbal and written communication skills
- Very good interpersonal and negotiation skills
- Fluent in local language and English, both written and verbal
Your responsibilities
- Management and oversight of ethics and regulatory (including periodic and local safety submission as applicable) activities in accordance with applicable laws and regulations, applicable Companyâs and/or Clientâs/Sponsorâs Controlled Documents (CDs), current Good Clinical Practice (GCP), current ISO 14155 norm (if applicable) and current MEDDEV (under Directive) / MDCG (under Regulation) guidelines concerning clinical investigations
- Oversight of site contracts/budgets (contracts with Institutions, Principal Investigator and other study site staff, as applicable as per local regulations, as well as contracts/budgets with external/satellite facilities that are involved with study conduct at a particular site such as laboratories, radiology facilities, etc. - all collectively called âsite contractsâ) management, negotiations and administration process, in accordance with Sponsor/Client and Company requirements
- Act as a mentor and be responsible for line management of the assigned team members of the Regulatory Affairs Department
- Coordinate communication and collaboration between Regulatory Affairs Department, Client and other relevant departments, in order to ensure that deliverables and milestones on the assigned projects are met according to both, Company and Client requirements
- Preparation of study submission strategy, project plans, and necessary documents and/or appropriate guidelines, and be a key Client contact for assigned project(s) during the start-up phase
- Reviewing essential documents required for the Investigational Medicinal Product or Investigational Medical Device release to the assigned investigational sites
- Oversight of the submissions of applicable periodic or local safety reports from clinical trials to the ethics committees and regulatory authorities in accordance with relevant laws and regulations
By joining our fast-growing and prosperous team, you will have a great opportunity for further personal growth and career development.
If you would be interested in joining the Optimapharm team, please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for the further selection process.
