Manager, Study Start Up and Regulatory Affairs

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

📋 Description

• Formulate regulatory strategies aligned with regulatory requirements.

• Coordinate and manage study start-up deliverables from site selection to site initiation readiness.

• Assist senior management in new business development through involvement in business development meetings and contributions to proposals and budgets.

• Lead study start-up and regulatory functions for projects of medium to high complexity.

• Oversee the complete study start-up process and regulatory milestones.

• Gather, review, and monitor essential study start-up documentation.

• Investigate any incomplete, inaccurate, or missing documents.

• Prepare reports and status updates for the study team.

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

• Identify, evaluate, and mitigate risks that may impact timelines.

• Cultivate relationships with clients, regulatory bodies, and internal stakeholders.

• Track project budgets and hours against allocated amounts; report on out-of-scope work.

• Develop and review sections of regulatory proposals, including cost estimates and budgets.

• Offer strategic insights for bids and assist in securing new business.

• Mentor, guide, and provide performance feedback to team members.

• May be responsible for line managing staff.

• Carry out other assigned job-related duties.

⛳️ Requirements

• Graduate degree in Chemistry, Life Sciences, Nursing, or a relevant combination of education and experience.

• 6–8 years of experience in the pharmaceutical or CRO industry, or with a regulatory body.

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

• Demonstrated capability to effectively manage global projects.

• Comprehensive understanding of regulatory requirements and study start-up processes.

• Proficiency in managing medium to high-complexity global projects.

• Skill in developing regulatory strategies, proposals, regulatory costings, and budgets.

• Competence in managing project timelines, budgets, deliverables, risks, and issues.

• Ability to provide strategic regulatory guidance, training, coaching, and mentoring.

🏝️ Benefits

• Collaborative, international team environment.

• Flexible work culture.

• Emphasis on work-life balance.

• Opportunities for career growth.

• Supportive workplace culture.

• Coaching, guidance, and performance feedback.

• Chance to engage in impactful clinical research that contributes to delivering safe and effective treatments to patients.