In the role as Senior Consultant Regulatory CMC you will be working on projects from a variety of Pharmaceutical and Biotechnology companies. On the projects you will be dealing with challenging and varied tasks that requires you to be result and client orientated and to display excellent interpersonal skills.

KLIFO is a leading drug development consultancy with significant experience in of regulatory affairs, clinical research, clinical trial supply, CMC development,

Regulatory Consulting CMC Cell & Gene Therapy Quality Lifecycle Key Responsibilities: Responsible for providing regulatory CMC support through the product life cycle (e.g., regulatory strategies, submission timeline development, change control and preparing submission documents). Create high quality, compliant CMC regulatory documents (eg, Core Dossiers, INDs, CTAs, MAAs, BLA, Variations and other relevant Engage proven CMC regulatory consultants to lead or support regulatory filings of developmental or approved products and respond to questions from regulatory bodies. Dossier Authoring Gain experienced interim talent to create CMC documentation for regulatory submissions, including characterization of the API (active pharmaceutical ingredient) of drugs. Independent CMC/Quality regulatory affairs consultancy, offering strategic advice and practical assistance with due diligence and dossier evaluation (gap analysis), regulatory project planning, dossier preparation, submission and follow-up for all types (MAA/NDA, IMPD/IND) of Global (European, US, Japan…) regulatory submissions.

Explore new ways to create your resume! Our CMC/Pharmaceutical Consultant Resume Example gives you great advice on what your final document should Veristat offers regulatory consulting expertise - strategic regulatory planning, or investor presentations of the clinical development, CMC, regulatory and/or DataRevive USA, LLC is a global regulatory consulting firm that provides and Controls (CMC) consultant with regulatory or technical writing experience for We are scientific and regulatory professionals who work closely with our clients to manage CMC, Compliance & Quality Scientific & Regulatory Consultants. Our global regulatory strategic consulting and operational services support your product throughout the Experts in non-clinical and CMC requirements Add the frequent lack of CMC regulatory compliance experience in some companies, coupled with the complexity of the biological manufacturing processes and Insights. BioPharma companies and Medical Devices manufacturers face growing operational, regulatory and economic challenges. ICON provides analysis and IND, NDA/BLA, ANDA, IDE, 510(K), PMA Preparation. Submissions & Publishing & eCTDs; CMC Strategy; Advertising & Promotion; Drug & Device Labeling Advice and consultancy; CMC Gap Analysis; Data collection and collation; Adjudication; Remediation; Project management; Health Authority communication.

In 2010 Dr. Golec founded CMCRegAff, LLC with the primary focus to provide strategic, senior level, executive CMC Regulatory Sciences consulting services to the pharmaceutical and biopharmaceutical industries on small molecule Drug Substance and Drug Product dosage form for all CMC regulatory phases during the Investigational New Drug (IND, CTA) development and planning, submission and … CMC Consulting Services.

CMC RA consultants can “provide the knowledge, experience, guidance, and advice to help most effectively and efficiently achieve the highest probability of success in obtaining regulatory approval of a particular pharmaceutical product.” Who is CMC Regulatory Affairs a good career choice for, and how does one start a career in this area?

Expert Regulatory Affairs consultants specializing in drug development, CMC regulatory, technical & project management for pharmaceutical, healthcare GMP, GCP Our consultants come with experience in CMC, Clinical, and Regulatory for biologics, biosimilars, and large and small molecule product development. With their expertise and our breadth of comprehensive resources, we can implement the full insourcing solution, functional team, or hybrid strategy that is most effective for your clinical or nonclinical drug development. Senior Director, CMC Regulatory Affairs (Pharmaceutical) Princeton, New Jersey Are you an established leader in Regulatory Affairs with deep expertise in Chemistry Manufacturing & Controls (CMC…Director is responsible for strategic CMC regulatory guidance during drug development, approval, post-approval, and commercialization, in coordination with internal staff and external consultants… Represents Regulatory Affairs CMC function, as required, at various cross-functional team meetings and working group meetings, providing solutions when possible to the project teams on CMC related problems.

IND, NDA/BLA, ANDA, IDE, 510(K), PMA Preparation. Submissions & Publishing & eCTDs; CMC Strategy; Advertising & Promotion; Drug & Device Labeling

Over the years, CMC breadth and depth was developed to support several needs of clients, both small and large biopharma. Chemistry, Manufacturing and Controls (CMC) Consulting | CMIC Group. CMIC Groups’ CMC Consulting team supports our customers with evaluation of CMC data through Gap-Analysis for conducting clinical trials in Japan (CTN) and/or New Drug Application (J-NDA) filings in Japan. Key Responsibilities: Responsible for providing regulatory CMC support through the product life cycle (e.g., regulatory strategies, submission timeline development, change control and preparing submission documents). Create high quality, compliant CMC regulatory documents (eg, Core Dossiers, INDs, CTAs, MAAs, BLA, Variations and other relevant Consultant CMC Regulatory Affairs in Breda, Netherlands.

Handla över 10.000 produkter. Sök efter nya Regulatory affairs manager to astrazeneca-jobb. Temporary staffing, permanent placement, consultants provided on site You may also support externalisation projects and transfer of CMC documentation to external partners. Temporary staffing, permanent placement, consultants provided on site We are looking for Regulatory CMC Associates to our product teams located in of regulatory CMC documentation. Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries.
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Involvement in API Vendor selection and Quality Agreements to provide critical assessment and solutions for strategic CMC issues related to API Contract Manufacturing Organizations (CMOs).

Apply to Consultant, Principal Consultant, Senior Consultant and more! We have extensive experience in providing regulatory, product development and quality systems consulting services to developers and manufacturers. Medical Device development and regulatory approval processes are both complex and highly nuanced. We’re the experts you want on your team.
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New cmc regulatory consultant careers are added daily on SimplyHired.com. The low-stress way to find your next cmc regulatory consultant job opportunity is on SimplyHired. There are over 204 cmc regulatory consultant careers waiting for you to apply!

CMC Project Manager - Biologics. Manufacturing.

Ikea julen 2021
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REGULATORY EXPERT – CMC PHARMACEUTICAL CONSULTANT The client, a global pharmaceutical company, faced challenges in workload when they

Chemistry, Manufacturing & Controls (CMC). Overcome regulatory, scientific and technical challenges ensuring compliance, flexibility on the production capability REGULATORY EXPERT – CMC PHARMACEUTICAL CONSULTANT The client, a global pharmaceutical company, faced challenges in workload when they Katalyst HealthCares & Life Sciences is currently looking for Regulatory CMC Consultant near Boston. Full job description and instant apply on Lensa. Jul 14, 2020 CMC consultants can help educate investigational new drug application (IND) sponsors (also known as clients), helping them to address any Feb 9, 2021 As a Senior Consultant, Regulatory CMC, you will be responsible for managing multiple regulatory programs for emerging biotechnology and This organization is not BBB accredited. Consultant in Apex, NC. See BBB rating Business Profile.

Our consultants draw upon PPD's internal regulatory affairs knowledge and expertise in preclinical; chemistry, manufacturing and controls (CMC); and clinical

We deliver global strategic regulatory consulting, dossier management services and GMP Quality services. As Regulatory Affairs Är du intresserad av att arbeta med Regulatory affairs-arbete inom läkemedelsbranschen 20 jan 2021. Unit4 logotyp · Technical Consultant · Unit4 Solna Job Description In the role as Regulatory Affairs Consultant you will be working on projects from a variety of Regulatory Account Manager (CMC). Södertälje. Här hittar du information om jobbet Head of CMC Regulatory Affairs within have a senior role as consultant or within a pharmaceutical authority within CMC. Helena Lindberg, Director Clinical & CMC Compliance, Global GxP Compliance and… 1d QP/RP Quality Assurance Consultant (REF7142Z).

We provide the expertise necessary to deliver quality CMC regulatory dossiers that expedite product approvals. With 30 years of pharmaceutical experience and over 20 years experience in CMC Regulatory Affairs, Lewis CMC Consulting has the knowledge and the experience that you are looking for.