Principal Non - Clinical Biostatistician GlobalHunt

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for contributing to the reliability, scientific quality, and optimization of project support throughout the entire process from target identification to process development. This will involve performing statistical analyses of data generated in the laboratories using R and potentially other programming languages to generate statistical reports. Additionally, you will play a key role in the development and maintenance of statistical end-user tools. Your expertise will be utilized in representing statistics within various scientific or technology working groups and cross-functional initiatives. To excel in this role, you should possess a strong background in non-clinical statistics as applied to biopharmaceutical development. Your proven experience in industrial statistics, including descriptive and inferential statistics, statistical process control, design of experiments, multivariate data analysis (such as PCA, PLS, and related methods), and statistical modeling and simulation will be crucial. A sound understanding of statistical concepts and techniques, such as predictive modeling and repeated measure ANOVA, is essential. Additionally, familiarity with pharmaceutical research and development, particularly in in-vitro testing, is desirable. Knowledge of CMC regulatory guidelines from organizations such as EMA, FDA, and ICH Quality, as well as QbD principles, will be valuable in this role. Your ability to prepare statistical analyses for regulatory dossiers and ensure compliance with relevant guidelines will be pivotal to the success of the projects you are involved in.,

Posted 1 week ago

Apply

Dy.Manager Regulatory Affairs - Injectable( US / EU / Canada) , Thane Hector And Streak Consulting

8.0 - 10.0 years

14 - 16 Lacs

Thane

Work from Office

We are looking DM RA with leading pharma company in Thane. Experience in Injectable regulatory affairs pre approval & post approval experience is must. Regulatory Submissions New Project Assignment This role involves the assignment and management of new projects for regulatory submissions, playing a pivotal part in the preparation and timely submission of high-quality regulatory documents across the US, EU, UK, and Emerging Markets. The position demands a strong understanding of global regulatory requirements, excellent communication skills, and effective cross-functional collaboration to ensure successful outcomes. Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related scientific discipline Diploma in Regulatory Affairs preferred Technical and Professional Expertise Demonstrated experience in regulatory affairs with a focus on submissions for the US, EU, UK, and Emerging Markets Solid understanding of ICH guidelines, ASEAN CTD requirements, and eCTD publishing standards Practical experience in the preparation, review, and submission of regulatory documents Familiarity with Quality by Design (QbD) principles and data trend analysis Experience 5 to 10 years of relevant experience in regulatory affairs Key Personal Attributes Excellent verbal and written communication skills Strong interpersonal and collaboration abilities Capable of working independently and managing multiple projects simultaneously Domain and Functional Competencies In-depth knowledge of international regulations (e.g., FDA, EMA, ICH) Up-to-date with evolving regulatory frameworks and compliance requirements Proficient in compiling,reviewing, and submitting comprehensive regulatory dossiers Ensures completeness, accuracy, and adequacy of all documents required for product approvals

Posted 1 month ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.