Regulatory Manager – Senior Regulatory Manager

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

📋 Description

• Deliver regulatory strategy and development support for clinical trials, meetings with regulatory agencies, orphan designations, pediatric planning, and expedited procedures.

• Ensure the prompt preparation of organized, high-quality regulatory submissions that comply with relevant regulations.

• Coordinate and prepare regulatory documentation for submission to Regulatory Authorities and/or Ethics Committees.

• Offer regulatory guidance throughout the clinical development lifecycle.

• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications.

• Develop and review documents for submission to Regulatory Authorities and Ethics Committees.

• Represent Global Regulatory Affairs in project team and business development meetings with both internal and external stakeholders.

• Collaborate within project teams and lead regional or global projects as necessary.

• Supervise and coordinate Regulatory Affairs Specialists to meet submission targets.

• Maintain project plans, trackers, and regulatory intelligence tools; provide updates to Regulatory Leadership.

• Assist in the development of Regulatory Affairs Specialists and other operational personnel.

• Contribute to regulatory strategy and timeline development for new study opportunities.

• Aid in establishing company standards for high-quality submissions.

• Engage in corporate quality initiatives across Clinical Solutions business units.

• Keep abreast of laws, regulations, and guidelines governing drug development and approval.

• Provide guidance, advice, and training on ICH GCP to both internal and external clients.

⛳️ Requirements

• Bachelor's degree or equivalent experience, preferably in a scientific or healthcare field.

• 5 years of regulatory experience required for the Manager level and 7 years for the Senior Manager Regulatory level.

• In-depth understanding of all facets of the drug development process, including regulatory milestones.

• Specialized knowledge of regulatory activities in at least one major region (EU, US).

• Experience with submissions to Regulatory Authorities, including INDs/CTAs and amendments, as well as Scientific Advice Procedures and post-approval submissions.

• Background in regulatory affairs working for a CRO or in the Pharmaceutical Industry.

• Proven experience leading Clinical Submissions.

• Ability to comprehend clinical and pre-clinical study outcomes and interpret them for regulatory strategies and positions.

• Familiarity with clinical trial methodologies, including a working knowledge of protocols and indications under study.

• Expertise in relevant regulations and guidance that support pharmaceutical development.

• Willingness to travel domestically and internationally, including overnight stays.

• Strong interpersonal skills with the ability to contribute effectively within a team environment.

• Understanding of financial management principles.

• Capability to manage multiple and diverse tasks in a dynamic environment.

• Excellent record-keeping abilities.

• Competence to work and plan autonomously as well as collaboratively in a team setting.

• Aptitude for resolving project-related challenges and prioritizing workloads to meet deadlines with minimal management oversight.

• Skill in collecting data of consistently high quality.

• Proficient in verbal and written communication in English.

• High proficiency in delivering formal presentations to colleagues, investigative staff, and clients.

🏝️ Benefits

• Employees are recognized and valued for their contributions.

• Employee ideas are appreciated and nurtured.

• Commitment to equal opportunity employment.

• Reasonable accommodation support for applicants with disabilities.