Senior Regulatory and Start-up Specialist - Romania

Optimapharm .

6d•Remote

About The Position

Optimapharm is seeking a Regulatory and Start-up Specialist to support regulatory submissions and study start-up activities across global clinical trials. This role is ideal for an experienced professional ready to take on increased responsibility and impact in a Senior position. Optimapharm is a leading, mid-sized, full-service CRO operating in Europe and North America, dedicated to delivering new therapies and improving patients' lives. With a strong track record and a collaborative approach, Optimapharm optimizes clinical trial design and planning.

Requirements

Degree in life sciences (e.g. pharmacy, biology, medicine, or similar).
4+ years of experience in regulatory and start-up activities within a CRO or 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 problem-solving skills with a proactive and solution-oriented mindset.
Good communication skills and confidence working with clients and cross-functional teams.
Comfortable using MS Office tools and clinical systems.
Fluent in English (written and spoken).

Nice To Haves

Additional languages are a plus.

Responsibilities

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 start-up phase.
Plan and drive submission strategies, timelines, and start-up activities, ensuring efficient study initiation.
Work closely with Project Management, Clinical Operations, and Quality teams to support smooth study set-up.
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 start-up challenges.
Ensure all documentation is accurate, complete, and inspection-ready.
Contribute to process improvements, knowledge sharing, and support of junior team members.