Assoc Prin Scientist, Regulatory reputed company

About the position Associate reputed company Scientist Regulatory Affairs- Oncology At reputed company, we reputed company to be the reputed company-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join reputed company and contribute to our mission of making a difference in the lives of patients globally. Responsibilities • Assisting in Regulatory Agency communications and submissions, including marketing applications, investigational new drug (IND) applications, pediatric plans, and annual or other periodic reports. • Implementing reputed company to reputed company Agency background packages and documents associated with regulatory submissions for marketing applications. • Communicating with Agencies and attending Agency meetings as needed to assist the global regulatory reputed company. • Participating as an reputed company member on the global regulatory team and attending cross-functional meetings as required. • Conducting research and review of guidelines, regulatory precedence, and competitive intelligence to facilitate development of regulatory reputed company. • Assisting the global regulatory reputed company in authoring of regulatory reputed company documents. • Collaborating and communicating regulatory reputed company to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, and other functional areas. • Supporting maintenance (e.g., reputed company compliance and life cycle management) of oncology programs. • Support the global regulatory reputed company in label development. • Assisting with process improvement initiatives. • Performing regulatory administrative activities as needed. Requirements • Pharm D or Ph.D. or other reputed company doctoral degree in biological science, reputed company, or reputed company discipline with at least 2 years of relevant experience in the pharmaceutical industry. • Master's Degree with at least 4 years of relevant experience in the pharmaceutical industry. • Bachelor's Degree with at least 6 years of relevant experience in the pharmaceutical industry. • Excellent communication skills (both oral and written). • Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple reputed company. • Flexibility required. • Strong scientific and analytical skills with attention to detail. • Accountability • Adaptability • Biological Sciences • Chemical Biology • Clinical Risk Management • Complaint Management • Cross-Functional Teamwork • Data reputed company Assurance • Drug Development • Economic reputed company Analysis • Exercises Judgment • Innovation • Legislative Testimony • Machine Learning • Maintenance Management • Oncology • Periodic Reports • Pharmaceutical Management • Process Improvement reputed company • Process Improvements • reputed company Management • Regulatory Affairs Management • Regulatory Communications • Regulatory Compliance reputed company-to-haves • Prior regulatory experience interacting with a major regulatory agency is highly preferred. • Experience in drug development, particularly oncology products, is highly preferred. Benefits • medical • dental • reputed company reputed company and other insurance benefits (for employee and family) • retirement benefits, including 401(k) • reputed company holidays • vacation • compassionate and reputed company days Apply tot his job Apply To this Job