Job description

📌Location: home-based

Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients’ lives.

Optimapharm’ 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.

We are seeking an accomplished Senior Regulatory and Start-Up Specialist (Sr RSUS) to join our team in UK. If you are a detail-oriented professional with a deep understanding of regulatory submissions and site startup strategies, and you thrive on driving clinical trial success, we want to hear from you!

This position not only offers a challenging and rewarding opportunity but also serves as a stepping stone toward a Manager role for high-performing candidates.

🎁 What do we offer?

Working in a successful company that’s growing and changing every day
Working with a highly experienced team of the clinical research professionals
International projects and professional growth
Performance bonus
Training opportunities

🔎 Who are we looking for?

💼 Qualifications And Experience

University degree in Medicine, Pharmacy, Life Sciences, or equivalent combination of education, training, and experience
At least 4 years of experience in regulatory and start-up activities with proven expertise and strong knowledge of Ethics, Regulatory, and Safety reporting requirements
Comprehensive understanding of the drug development process, GCP, ICH Guidelines, ISO 14155, and relevant MEDDEV/MDCG clinical investigation guidelines
Knowledge of local regulatory requirements/guidelines/ personal data privacy laws and international industry standards (GCP ICH, CFR FDA and EU Directives/Regulations)
Experience in clinical research within CROs and/or BioPharmaceutical settings, including site contracts and team collaboration
Proficiency in computer systems (e.g., Excel), technical problem-solving, and the ability to manage abstract and complex variables
Strong written, oral, administrative, and presentation skills; ability to communicate effectively with internal and external stakeholders
Skilled in time management, multitasking, and working independently in fast-paced, team-oriented environments
Affinity for mentoring and supervising, with a proactive, diplomatic, and reliable approach
Strong problem-solving, negotiation, and customer service skills, with a focus on building relationships and achieving results

📑 Your responsibilities

Manage ethics and regulatory submissions for clinical trials in compliance with applicable laws, regulations, and guidelines, including SOPs, GCP, ISO 14155, and MEDDEV/MDCG guidelines.
Negotiate, manage, and administer site contracts and budgets, including agreements with institutions, principal investigators, study site staff, and external facilities involved in study conduct.
Prepare and implement country-level study submission and site startup strategies.
Provide input on project plans, documents, and guidelines.
Act as the primary Client/Project contact for assigned countries/sites during the start-up phase.
Serve as a point of contact for country-specific regulations and processes.
Mentor newcomers and train team members on country-specific SOPs, work instructions, and submission processes.
Develop training presentations and participate in the creation of SOPs/WIs.
Prepare and review essential documents required for Investigational Medicinal Product or Device release to investigational sites.
Manage submissions of periodic or local safety reports to ethics committees and regulatory authorities in compliance with relevant laws and regulations.

If you would be interested in joining the Optimapharm team, please send your CV and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.

Required profile