Regulatory Affairs Expert - Pharma (m/f/x) | hybrid We are looking to strengthen our team with a Regulatory Affairs Specialist (m/f/d) who will support our clients in regulatory approval projects. What are your responsibilities as a " Regulatory Affairs Expert (m/f/x)"?Document Creation and Organization: You will be responsible for creating, organizing, and managing documents, particularly CMC documentation, US micro packages, quality management system and validation overviews, as well as statements and confirmations.CTD Module Development: You will create CTD modules and conduct CTD reviews to ensure the quality and completeness of the documentation.Site Accreditation and Registration: You will manage the submission and receipt of site accreditation and site registration.Client and Regulatory Inquiries: You will evaluate and respond to inquiries regarding regulatory affairs topics to ensure smooth communication.Handling of Deficiencies: You will be responsible for addressing deficiency complaints and developing solutions to optimize processes. What requirements should you bring as a "Regulatory Affairs Expert (m/f/x)"?A degree in pharmacy, life sciences, or a related field.In-depth knowledge of regulatory affairs, particularly in the creation of submission documents and CTD documentation.Experience in communication with regulatory authorities and clients.Strong organizational skills and a structured approach to work.Excellent communication skills and ability to work with cross-functional teams.Fluency in both German and English. What does the company offer you?Contract type: Permanent full-time contract.Vacation: 30 days/yearHome office: Up to 40% remote/mobile.Working hours: 40 hours/week.A dynamic work environment with a flat organizational structureOpportunities to quickly take on responsibility and make a meaningful impactStart date: As soon as possible My contact details:Email: m.inderhees@sciproglobal.deTel: 0049 (0) 89/26 20 09 25 (direct dial)LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b Are you interested in this position? Then you should apply now! If you desire additional or alternative job opportunities, I also welcome your application. I look forward to receiving your application!

SciPro is excited to share an extraordinary opportunity with our key client in Colorado who is seeking a Principal Scientist to Associate Director of ADCs to join their innovative team.This is not just another role-our client is backed by a former C-Suite executive from one of the largest global software companies, and they are at the forefront of developing safer and more effective cancer therapies using antibody-drug conjugates (ADCs). They're pioneering a novel approach that enables programmable entry into tumor cells, and you could be part of this groundbreaking mission.Position Overview:We are seeking a dynamic Scientist to join this forward-thinking team. This position offers a unique opportunity to make an immediate impact within a highly visible role. This role reports directly to the CSO and works closely with the CEO to shape and drive the strategy for the protein team. The role is hands-on (70% benchwork) while also offering managerial responsibilities, as you lead a talented four-member team focused on ADC production and analytics.Key Responsibilities:Lead the purification and characterization of proteins, particularly antibodies derived from mammalian cells.Develop and implement strategies to enhance the team's capabilities in ADC research and development.Manage and mentor a group of highly experienced scientists, fostering an environment of collaboration and innovation.Collaborate cross-functionally to integrate cutting-edge technologies in drug discovery and development.Drive the execution of projects with a focus on achieving high throughput in antibody design and functional assessments.Requirements:PhD in a relevant field with a strong background in protein purification and characterization.Strong chemical conjugation, and antibody analytical characterization skills (HPLC HIC and SEC, Maleimide chemistry, NHS ester chemistry).Proven expertise in the development and application of ADCs.Must have held at least 2 to 3 direct reportStrong written and verbal communication skills, with the ability to convey complex scientific concepts effectively.

Overview A top mid-sized biopharma company out of the Boston area is hiring for a Director of Clinical Pharmacology. This position is can provide remote flexibility. This company is global biotechnology company with multiple commercialized drug products in the U.S and a great reputation in the space. This company operates in a few different therapeutic areas and requires a senior member to join their clinical pharmacology team and lead strategic decision making to develop their clinical pipeline. You will be acting as a SME in clinical pharmacology working with internal and external teams. You will be using the model informed drug development paradigm to facilitate drug development. As well as providing input to all applicable clinical development plans, protocols, and clinical study reports. You will work on regulatory submissions and represent Clinical Pharmacology at meetings with regulatory agencies. This individual will also help develop strategy to streamline processes in the Clinical Pharmacology group. What would you be doing? Serve as a Clinical Pharmacology SME for early development and late stage clinical projects. Provide guidance on lead modalities and programs to various teams working to determine the right target, molecule, dose, patient population and strategies. Apply knowledge in PKPD and relevant analysis (experience reviewing datasets in R or NONMEM is a plus) to strategize and predict exposure-response as well as dosing. Working closely with multiple different cross functional teams such as PMX to develop study protocols (Phase I – III). Advise on various regulatory documents (INDs, IBs, CDTs). Collaborate with various regulatory agencies (FDA, EMA, PMDA). Requirements: PhD required in pharmaceutical sciences, pharmacology, or related field At least 8+ years in the biotechnology or pharmaceutical industry Experience with clinical pharmacology and PKPD modeling, exposure-response or dose selection Experience with clinical PK data and data analysis (Phase I-IV) Experience in NONMEM and/or R (nice to have) Excellent communication skills