Manager, Study Start Up and Regulatory Affairs

This is a fully remote position, open to applicants in Italy.

📋 Description

• Formulate regulatory strategies in alignment with regulatory standards.

• Organize and supervise study initiation deliverables, from site selection to site readiness for initiation.

• Direct study initiation and regulatory efforts for assigned projects of medium to high complexity.

• Oversee comprehensive study initiation and regulatory milestones.

• Gather, evaluate, monitor, and address issues concerning essential study documents.

• Generate reports and updates for the study team regarding the status of document collection, review, and approval.

• Negotiate and finalize clinical site agreements, ancillary contracts, and amendments.

• Recognize, evaluate, and mitigate risks that affect study initiation and regulatory timelines.

• Establish and nurture relationships with clients, regulatory bodies, and internal stakeholders.

• Track departmental deliverables, project budgets, and hours in relation to the budget.

• Engage in business development meetings and either create or review sections of regulatory proposals.

• Offer coaching, guidance, training, mentoring, and performance feedback to junior team members.

• Manage staff as necessary.

• Carry out other assigned job-related tasks.

⛳️ Requirements

• A graduate degree in Chemistry, Life Sciences, Nursing, or an equivalent combination of education and experience.

• 6–8 years of experience in the pharmaceutical or CRO sector, or a regulatory agency.

• A minimum of 3 years in a leadership or project management position.

• Demonstrated ability to effectively manage global projects.

• Knowledge of regulatory requirements and study initiation processes.

• Capability to manage projects with medium to high complexity.

• Proficiency in developing regulatory strategies and overseeing study initiation deliverables.

• Expertise in managing clinical site agreements, ancillary contracts, and amendments.

• Skill in identifying, assessing, and mitigating risks related to study initiation and regulatory processes.

• Competence in monitoring project budgets and addressing out-of-scope work.

• Ability to provide strategic insights into bids, proposals, regulatory costing, and budgets.

🏝️ Benefits

• Collaborative, international team atmosphere.

• Flexible work-life balance.

• Opportunities for career advancement.

• Access to coaching, guidance, and mentoring.

• Chance to engage in impactful research in rare diseases and oncology.

• Opportunity to contribute to new business proposals and business development initiatives.

• A diverse and inclusive work environment where every voice is valued.