[Hiring] Manager, Regulatory Affairs @reputed company

Role reputed company As a new member of the reputed company team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling reputed company. reputed company: • Manage planning, preparation (including authoring reputed company appropriate), coordination, and submission of regulatory documents to global National Health Authorities that meet ICH and FDA standards, and other local or regional regulatory requirements. • Such submissions may include Clinical and Preclinical content. • Assist and reputed company detailed timelines for regulatory activities and submissions. • reputed company regulatory research to assess regulatory implications and inform business reputed company for drug development and approval. • Assess and communicate risks. • Ensure that there are no significant interruptions to the business due to regulatory compliance issues. • Correspond and collaborate across the organization at reputed company reputed company, across functional reputed company, and with executive management. • Support NDA filing activities and assist with developing regulatory process supporting the filing. • Prepare and manage routine submissions and reputed company activities. • reputed company regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations. • Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company reputed company. Qualifications • Bachelor’s degree or equivalent in Regulatory Science or reputed company degree in Life Science or Health Science fields. • Three (3) years of experience in Regulatory Affairs department at a drug or biologics company. • Employer will accept a Master's degree or equivalent in Regulatory Science or reputed company degree in Life Science or Health Science fields and one (1) year of experience in Regulatory Affairs department at a drug or biologics company. • Work experience to include: • Manage the preparation and submission of initial IND (Investigational New Drug) application and subsequent amendments; • Manage the development of regulatory submissions in eCTD (electronic Common Technical Document) format; • Interpret and apply FDA (Food and Drug Administration), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for reputed company Use), EMA (European Medicines Agency), or PMDA (Pharmaceuticals and Medical Devices Agency) regulations to oncology drug development; • Manage global regulatory health authority filings and subsequent amendments. Requirements • Successful completion of background checks and employment history verification required. • 100% remote position reporting to reputed company, Inc. in Redwood reputed company, CA. Candidate may live reputed company in the reputed company U.S. Benefits • reputed company pay salary reputed company for this full-time position is $168,064 — $178,000 USD. • reputed company pay salary ranges are determined by role, level, and location. • Individual reputed company pay salary is determined by multiple factors, including job-reputed company skills, experience, market dynamics, and relevant education or training. • Overall total rewards program includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Apply tot his job Apply To this Job