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 working with an exciting global pharmaceutical company on a Lab Head search. This is an exciting technical and people management opportunity, where the selected candidate will be responsible for all aspects of NMR lab operations for chemical research teams.   Candidates with the following experience will be successful in this opportunity: Track record of drug discovery innovation Subject matter expert in Nuclear Magnetic Resonance (NMR) Experience managing junior scientists directly, and a passion for mentorship within the pharmaceutical space Educational background in chemistry-related field (organic chemistry, analytical chemistry, etc.)   If this opportunity interests you, please apply below, or email a resume to n.gale@sciproglobal.com.

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