Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual timelines are met. You will provide leadership for assigned projects regarding all regulatory activities that lead to start up of clinical trials. Responsibilities: - Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards - Coordination of regulatory timelines and deadlines for all assigned projects planned for CTIS submissions. Includes oversight of EU (mainly), APAC, and North America submissions. - Review of regulatory documents and submissions created outside of the company by subcontractors (eg, partner CROs, regulatory vendors) to ensure high quality standards before submission to CTIS - Point of contact for Sponsors and subcontractors/project management teams for all aspects related to study regulatory submissions - Preparation or review of country specific Patient Information Sheet/Informed Consent form documents. - Preparation or review of study-specific templates of regulatory forms. - Manages translation requests with vendor. - Regulatory support and advice to project teams and key internal/external customers on local requirements and EU submission strategy and technical expertise - Maintain high level knowledge about EU CTR and EU/EEA countries local requirements in the area of company interest. - Maintain the regulatory intelligence database - Participation in Kick-off meetings, audits, and other project related meetings according to the company / client needs Requirements Education - Bachelor's degree (or equivalent) in a scientific discipline Experience - Minimum of 2-3 years of clinical research experience (in CRO or Pharma) working in Poland regulatory affairs is required - Experience in initial CTA is essential - Experience in a sponsor facing role is an asset - Previous experience with CTIS is an asset - Hands-on experience preparing, reviewing, and submitting regulatory documentations Knowledge and skills - Excellent knowledge of applicable EU regional / national country regulatory guidelines (such as Poland, Spain, Germany, France, Netherlands) - Excellent knowledge of GCP and ICH standards - Fluency in English with excellent oral and written skills, required - Additional languages represent an asset - Excellent organization and communication skills, great attention to detail - Ability to organize own work, prioritize different assignments, and work under pressure; - Versatile and comfortable in a multitasking environment; - Respect established timelines, expectations, priorities, and objectives; Our company The work environment At Indero, you will work with brilliant and driven professionals. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. As a Regulatory Affairs Specialist you will be eligible for the following perks: - Permanent full-time position - Flexible schedule - Vacation - Home-based position - Ongoing learning and development About Indero Indero is a CRO specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Spain. Description de poste null Profil recherché null Notre entreprise null

• Provide regulatory subject matter expertise and guidance to retail firms • Support horizon scanning and communicate regulatory changes • Respond to ad-hoc compliance queries • Review and approve financial promotions • Manage risk registers and KRIs, providing oversight and challenge • Identify and report breaches, ensuring appropriate actions are taken • Assist with regulatory filings and submissions • Deliver risk and compliance training across the Broking Division • Support internal reporting for the Broking Risk & Compliance Committee • Review and update R&C owned policies in line with agreed review cycles and internal governance requirements • Provide data protection support to the Data Protection Officer, including compiling Data Subject Access Request responses in accordance with regulatory requirements and internal procedures • Oversee key contracts (e.g., TOBAs, Delegated Authorities) • Support compliance due diligence on acquisition targets • Support integration of newly acquired businesses and remedial actions

Founded in 1986, KPA is a leading provider of Workforce Compliance software and consulting services. We succeed if our clients can send their employees home at night, having not experienced a workplace accident or injury. The combination of software, consulting, and training helps clients identify, remedy, and prevent workplace safety and compliance problems so they can focus on what’s important – their core business. Help us help keep people safe and businesses working efficiently. Named as one of Built In Colorado’s Best Places to Work for seven years in a row, KPA is made up of talented individuals working together for the greater good. We’re here to help our clients build safe, thriving organizations, and we’re looking for people with a common goal to help us do it. Position Description: The Guided Compliance Consultant is responsible for driving the engagement and on-going success of KPA’s client base. The primary objective is to manage client relationships and educate and guide the client on regulations and rules put in place by Federal, State, and Local Regulatory Agencies. Responsibilities: • Research current and upcoming regulations or changes to the regulations. • Communicate clearly with the owners, executive management, champions, and department managers concerning any current or proposed regulations put in place by regulatory agencies. • Ongoing communication to educate and consult with clients through calls, regular interactions, emails, and quarterly reports and meetings. • Assist clients remotely during regulatory inspections conducted by Federal, State, or Local agencies. • Resolving client issues as part of the escalation process and manage until the issue is resolved. • Understand the full functionality of the KPA product suite, ABLE software, features and benefits, and competitive position to best support all clients. • Resolving client issues as part of the escalation process and manage until the issue is resolved. • Collect feedback to drive continuous improvement across all areas of the business. • Other duties as assigned by management. Success Criteria: • Ability to work independently and in a team environment with efficiency. • Experienced at problem solving, organizational and time management skills. • Dynamic personality with an effective communication style. • Must be self-motivated and goal oriented. • Clear and concise with both verbal and written communication. • Ability to understand process, identify improvements and implement change. Qualifications: • 2+ years in an Account Management or Field Consultant position. • Experience in the Finance or Fixed Operations departments of a dealership is a plus. • Experience with Microsoft Office (Word, Excel, Powerpoint, Outlook, etc.). • Communicate effectively with clients of all levels. • Patient, friendly, and direct when necessary. • Skilled at building long-term relationships with our clients. • Intellectually curious and able to think on your feet. Don’t meet every job requirement? At KPA, we are dedicated to building a diverse, inclusive, and authentic workplace. Studies have shown that women and people of color are less likely to apply unless they meet every requirement. If you’re excited about the role but your past experience doesn’t align perfectly with every qualification, we still encourage you to apply! You might just be the right candidate for this or other roles. As a growing company KPA values its employees by supporting them with a full benefits package including Medical, Dental, Vision, Flexible Spending Accounts, PTO, Paid and Floating Holidays, 401k with Company match and immediate vesting, Company-funded Life Insurance, Employee Assistance Programs, and No-cost Mental Health Benefits. About KPA Founded in 1986, KPA is a leading provider of Environment, Health & Safety (EHS), and Workforce Compliance software and consulting services. KPA solutions help clients identify, remedy, and prevent workplace safety and compliance problems across their entire enterprise. The combination of KPA's software, consulting services, and award-winning training content helps organizations minimize risk so they can focus on what's important—their core business. We are passionate about what we do, how we do and why we do it. Our culture is driven by the KPA core values – Integrity, Helpful, Excellence, Agile, Respectful, and Teamwork. Success will be determined by the capabilities, energy and character of the people we bring into our organization and the performance they achieve. KPA, with headquarters in Colorado and teammates throughout the United Sates, is recognized as one of Colorado's Best Places to Work to Work by Built In Colorado for 2025, making the list seven years running. KPA is committed to providing equal opportunity in all of our employment practices, including selection, hiring, promotion, transfer, and compensation, to all qualified applicants and employees without regard to race, religion, religious dress/grooming, color, ethnicity, sex (including sex stereotyping), sexual orientation, gender identity or gender expression, national origin, ancestry, citizenship status, creed, uniform service member status, military or veteran status, marital status, pregnancy, breast-feeding and/or pregnancy-related conditions, age, protected medical condition, leave status, physical or mental disability, genetic characteristics, or any other legally-protected status in accordance with the requirements of all federal, state and local laws. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. If you need assistance or an accommodation due to a disability, you may contact us at hr@kpa.io. Please see our Candidate Privacy Notice here

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Develop, publish, and support the publishing of regulatory submissions to global health authorities in alignment with established standards, requirements, and organizational commitments. Ensure all submissions are prepared in high-quality, compliant formats. Perform related activities as needed and provide support to both internal and external stakeholders. Required Qualifications: - 1–3 years of experience in regulatory publishing or document management within the pharmaceutical industry. - Experience working with XML or other structured document formats. - Foundational knowledge of eCTD structure and electronic submission requirements for global health authorities (FDA, EMA, Health Canada, etc.) - Proficiency with regulatory publishing systems such as Veeva, Extedo, Insight, DXC, or comparable platforms. - Solid understanding of eCTD structure, submission standards, and applicable regulatory guidelines. - Exceptional attention to detail with the ability to manage complex documentation and meet demanding timelines. Preferred Qualifications: - Familiarity with end‑to‑end submission lifecycle maintenance processes. - In-depth knowledge of FDA and international regulatory agency requirements. - Prior experience with document control or compliance‑driven workflows. - Strong background in document preparation and formatting. Skills: - Proficiency in Microsoft Word and Adobe Acrobat for document formatting, hyperlinking, and submission preparation - Ability to work effectively in a cross-functional team environment and manage multiple tasks under tight deadlines - The ability to quickly learn new software tools and systems. - Effective written and verbal communication skills Education: - Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (or equivalent work experience).