[All remote jobs](https://jobicy.com/jobs.md)[![Precision Medicine Group logo](https://jobicy.com/data/server-nyc0409/galaxy/mercury/2025/06/f1277044-221.jpg)](https://jobicy.com/company/precision-medicine-group.md)[Precision Medicine Group](https://jobicy.com/company/precision-medicine-group.md) # Regulatory Manager / Senior Regulatory Manager Review the role, location requirements, compensation details, and application process before deciding whether this opportunity fits your next career move. [Apply for this job](#job-application)[View company](https://jobicy.com/company/precision-medicine-group.md)ShareRemote from[Poland](https://jobicy.com/job-region/poland.md)SalaryPLN 190,200–285,400 / yrDepartment[Legal & Compliance](https://jobicy.com/categories/legal.md)EmploymentFull TimeExperienceSeniorPublished28 Oct 2026Apply before27 Nov 2026Listing views32Application actions2Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. AI Summary ## The role, at a glance. This senior regulatory affairs role supports clinical drug development programs within a CRO focused on oncology and rare disease. The manager will develop regulatory strategy, prepare and coordinate CTA/IND and other authority submissions, and provide regulatory guidance across the clinical development lifecycle. The position also represents Global Regulatory Affairs in project and business-development meetings, oversees specialists, and maintains plans and regulatory intelligence tools. Candidates need 5 years of regulatory experience for Manager level or 7 years for Senior Manager level, with CRO or pharmaceutical-industry experience leading clinical submissions. The role is remote in Poland and includes occasional domestic and international travel. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 5/5EasyHard ### Pace & Pressure 5/5RelaxedFast-paced ### Autonomy Level 5/5GuidedFull ownership ### Communication Load 5/5IndependentCollaborative AI insightThe role requires deep knowledge of global pharmaceutical regulations, clinical development, and complex submissions such as INDs, CTAs, orphan designations, and paediatric plans. It carries strategic responsibility, cross-functional leadership, deadline-driven delivery, and direct client and regulatory-authority interaction. ## Salary analysis Estimated compensation compared with the broader PLN market for similar roles. Estimated job median (per year)Market ratePLN237,800PLN market range (per year)PLN190k–PLN310k0PLN341k AI insightThe yearly pay period is inferred from the job context; it was not explicitly stated by the employer. The employer discloses a gross annual range of 190,200–285,400 PLN for Poland, with a midpoint of 237,800 PLN per year. This is a credible annual compensation range for an experienced regulatory affairs manager or senior manager in Poland. The estimated annual market range is 190,000–310,000 PLN and may vary by seniority, therapeutic-area expertise, CRO experience, and responsibility for global submissions. ## Core skills Skills and capabilities most closely associated with this opportunity. [Regulatory affairs](https://jobicy.com/jobs?search_keywords=Regulatory%20affairs.md)[Clinical trial regulations](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20regulations.md)[CTA submissions](https://jobicy.com/jobs?search_keywords=CTA%20submissions.md)[IND submissions](https://jobicy.com/jobs?search_keywords=IND%20submissions.md)[Regulatory strategy](https://jobicy.com/jobs?search_keywords=Regulatory%20strategy.md)[ICH GCP](https://jobicy.com/jobs?search_keywords=ICH%20GCP.md)[Pharmaceutical development](https://jobicy.com/jobs?search_keywords=Pharmaceutical%20development.md)[Clinical submissions](https://jobicy.com/jobs?search_keywords=Clinical%20submissions.md)[Regulatory intelligence](https://jobicy.com/jobs?search_keywords=Regulatory%20intelligence.md)[Orphan drug designation](https://jobicy.com/jobs?search_keywords=Orphan%20drug%20designation.md)[Paediatric investigation planning](https://jobicy.com/jobs?search_keywords=Paediatric%20investigation%20planning.md)[Health authority communications](https://jobicy.com/jobs?search_keywords=Health%20authority%20communications.md)[Project management](https://jobicy.com/jobs?search_keywords=Project%20management.md)[Clinical trial methodology](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20methodology.md)[Stakeholder management](https://jobicy.com/jobs?search_keywords=Stakeholder%20management.md) Sample interview questionsHow have you developed regulatory strategy for a clinical development program?I begin by reviewing the target product profile, nonclinical and clinical evidence, proposed indication, and the applicable regional requirements. I identify key regulatory milestones and risks, align submission sequencing and meeting plans with the development timeline, and update the strategy as new data or agency feedback becomes available. Describe your experience preparing CTA or IND submissions. I have coordinated cross-functional contributors to assemble core clinical, nonclinical, CMC, and administrative documents, while tracking document readiness and ensuring consistency across the dossier. I perform quality and compliance reviews, manage responses to authority questions, and maintain clear submission records and timelines. How do you manage competing submission deadlines across several studies? I use a risk-based plan with defined owners, critical-path milestones, document trackers, and regular status reviews. I escalate blockers early, prioritize activities that affect filing dates, and communicate realistic options to project leadership so that quality is not compromised under time pressure. How would you provide regulatory guidance to a project team unfamiliar with a particular region? I would explain the relevant requirements in practical terms, including the rationale, expected timelines, required evidence, and potential risks. I would then translate that guidance into clear actions and checkpoints for the team, supported by current regulatory intelligence and, where appropriate, local expert input. What is your approach to leading and developing Regulatory Affairs Specialists? I set clear expectations for quality, timelines, and ownership, then provide structured review feedback and coaching based on each person's experience level. I also involve specialists in planning and problem-solving so they build confidence in regulatory judgment as well as submission execution. Opportunity details ## About this role. Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. Precision for Medicine are recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join our growing global team. As a Regulatory Manager, you will provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organised, quality regulatory submissions in compliance with applicable regulations. You will be responsible for coordinating and preparing regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. Essential functions of the job include but are not limited to: * Provides regulatory guidance throughout the clinical development life cycle * Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required * Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards * Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers * Works within a project team, and where necessary, leads project for the region or globally * Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs * Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. * Assist in development of Regulatory Affairs Specialists and other operational area staff, as required * Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information * Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions. * Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval * Provides ICH GCP guidance, advice and training to internal and external clients * Serve as representative of Global Regulatory Affairs at business development meetings The ideal candidate will have the following: Minimum Required: * Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline * 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level * Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialised knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions. * Candidates must have regulatory affairs experience working for a CRO or within the Pharmaceutical Industry, and have experience leading Clinical Submissions Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy * Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied * Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development * Availability for domestic and international travel including overnight stays Competencies * Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities * Understanding of financial management * Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates * Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills * Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment * Motivates other members of the project team to meet timelines and project goals * Flexible attitude with respect to work assignments, and new learning * Resolves project related problems and prioritize workload to meet deadlines with little support from management * Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective * Collects data of consistently high standard * Communicates effectively in the English language both verbally and in written form * Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, private medical insurance, MultiSport Card, life insurance, pension, home working allowance, vacation, among other benefits. Reasonable estimate of the current range for Poland: 190,200 PLN gross per annum to 285,400 PLN gross per annum #LI-OS1 #LI-Remote We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company. 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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [myHR@precisionmedicinegrp.com](mailto:myHR@precisionmedicinegrp.com). Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [myHR@precisionmedicinegrp.com](mailto:myHR@precisionmedicinegrp.com) so we can investigate and take appropriate action. Candidates must be legally authorized to work in the country of employment without employer sponsorship. 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