Senior Regulatory and Start-up Specialist Germany

Location: home-based anywhere in Germany

Who we are

Optimapharm is a leading mid-sized full-service CRO working across Europe and North America to deliver new therapies to improve and save patients lives. Optimapharms key priorities are our people and consistently exceeding our clients expectations.

With 26 strategically located offices Optimapharm operates in 40 countries giving unrivaled access to Patients and Investigators in all countries in Europe and North America.

In-depth expertise and long-standing experience combined with a flexible and collaborative approach allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams Optimapharm has secured a high level of repeat business over the years.

We are looking for a Regulatory and Startup Specialistto support regulatory submissions and study startup activities across global clinical trials. This opportunity is well suited for someone with a solid foundation in the field who is ready to step up into a Senior position with increased responsibility and impact.

What do we offer

• Working in a successful company thats growing and developing every day
• Being part of a clinical research team that transforms science into hope for patients
• International projects and professional growth
• Working with a highly experienced team of clinical research professionals
• Performance bonus
• Referral bonus
• Flexible work hours
• Shopping discounts
• Employee engagement programs
• Well-being initiatives
• Training and development program

Who are we looking for

Qualifications andExperience

• Degree in life sciences (e.g. pharmacy biology medicine or similar)
• 4 years of experiencein regulatory and startup activities within aCROor pharmaceutical environment
• Solid understanding of clinical trial processes and the drug development lifecycle
• Strong knowledge of GCP ICH guidelines and regulatory submission requirements
• Experience with site contracts and budgets ideally with some involvement in negotiations
• Ability to work independently and take ownership of deliverables while managing multiple priorities
• Strong problemsolving skillswith a proactive and solutionoriented mindset
• Good communication skills and confidence working with clients and crossfunctional teams
• Comfortable using MS Office tools and clinical systems
• Fluent in English (written and spoken); additional languages are a plus

Yourresponsibilities

• Lead and coordinate ethics and regulatory submissions across assigned countries taking ownership of timelines quality and compliance
• Prepare review and submit clinical trial applications and regulatory documentation to ethics committees and health authorities
• Act as a key point of contact for clients and project teams during the study startup phase
• Plan and drive submission strategies timelines and startup activities ensuring efficient study initiation
• Work closely with Project Management Clinical Operations and Quality teamsto support smooth study setup
• Take an active role in site contract and budget activities including review negotiation support and coordination
• Proactively identify risks propose solutions and help resolve regulatory and startup challenges
• Ensure all documentation is accurate complete and inspectionready
• Contribute to process improvements knowledge sharing and support of junior team members
  

By joining our fast-growing and prosperous team you will have an excellent opportunity for further personal growth and career development.

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.

Compensation is competitive and final offers will reflect each candidates experience skills and qualifications.

Disclaimer: Unsolicited CVs sent to Optimapharm (Talent Acquisition Team Hiring Managers or any other OPT employee) by recruitment agencies will not be considered for this role. Optimapharm follows a direct sourcing strategy and collaborates exclusively with selected recruitment partners when external support is required.