Manager, Study Start Up and Regulatory Affairs

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

📋 Description

• Formulate regulatory strategies in alignment with regulatory requirements.

• Manage and oversee all aspects of study start-up deliverables from site selection to site initiation readiness.

• Support senior management in acquiring new business through participation in business development and contributions to proposals and budgets.

• Offer strategic regulatory advice, training, coaching, and mentorship to junior team members.

• Direct study start-up and regulatory tasks for assigned projects of medium to high complexity.

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

• Gather, review for completeness and compliance, and monitor essential study start-up documents.

• Investigate any incomplete, inaccurate, or missing documentation.

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

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

• Define and execute project-level strategies for study start-up and regulatory matters.

• Identify, evaluate, and mitigate risks that could impact study start-up and regulatory timelines.

• Develop and nurture relationships with clients, regulatory authorities, and internal stakeholders.

• Track assigned departmental deliverables, project budgets, actual hours compared to budgeted hours, and any out-of-scope work.

• Create and review regulatory segments of proposals, along with regulatory costing and budgets.

• Provide valuable input on bids and assist in securing new business opportunities.

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

• Manage staff members when necessary.

• Carry out other assigned work-related responsibilities.

⛳️ Requirements

• Master’s degree in Chemistry or Life Sciences, Nursing, or an equivalent combination of education and experience.

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

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

• Demonstrated ability to successfully oversee global projects.

• Experience with study start-up and regulatory affairs.

• Familiarity with regulatory requirements and country-specific regulations.

• Capability to manage medium- to high-complexity global projects.

• Proficient in developing regulatory strategies, proposals, regulatory costing, and budgets.

• Skilled in negotiating and executing clinical site agreements, ancillary agreements, and amendments.

• Ability to identify, evaluate, and mitigate risks associated with study start-up and regulatory processes.

🏝️ Benefits

• Collaborative, international team environment.

• Opportunities for career advancement.

• Flexible work setting.

• Emphasis on work-life balance.

• Access to coaching, guidance, and mentoring.

• Chance to contribute to impactful clinical research that delivers safe and effective pharmaceutical treatments to patients.