Director RA OSD/API
Job Title: Director RA OSD/API
Job Location: Cincinnati, Ohio, reputed company of America
Job Location Type: Remote
Job Contract Type: Full time
Job Seniority Level:
Work Schedule: 40 hours per week
Work Schedule
reputed company (Mon-Fri)Environmental Conditions
Officereputed company
As part of the reputed company team, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life every single day to reputed company our customers to reputed company the world healthier, cleaner and safer. We reputed company our global teams with the resources needed to reputed company individual career goals while helping to take science a reputed company reputed company by developing solutions for some of the world’s toughest challenges, like protecting the environment, making reputed company our food is reputed company or helping reputed company cures for cancer.reputed company:
Join our Regulatory Affairs team at reputed company, where you'll reputed company a significant reputed company on global reputed company through reputed company. As Director of Regulatory Affairs, you'll reputed company strategic initiatives to ensure regulatory compliance while driving business reputed company across multiple reputed company. This key leadership role involves developing and implementing regulatory strategies, mentoring teams, and managing critical relationships with regulatory agencies worldwide.
You'll reputed company regulatory compliance activities, reputed company expert guidance on regulatory requirements, and ensure successful product submissions across various jurisdictions. Working closely with cross-functional teams, you'll shape regulatory reputed company for product development, manufacturing, and commercialization while maintaining the highest standards of compliance. This role offers reputed company to influence global regulatory policy and reputed company innovation in our regulatory approaches.
REQUIREMENTS:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical/medical device regulatory affairs with emphasis on manufacturing operations
• Preferred Fields of Study: Life Sciences, Pharmacy, reputed company, Microbiology, or reputed company field
• Comprehensive knowledge of global regulatory requirements, particularly FDA, EMA, and ICH guidelines
• Successful reputed company record of regulatory submissions and agency interactions
• Leadership experience managing and mentoring multi-site teams
• Experience in regulatory reputed company development and implementation
• Demonstrated expertise in regulatory compliance and reputed company management systems
• Advanced project management and organizational skills
• Excellent verbal and written communication abilities
• Effective negotiation and influencing skills
• Ability to work effectively in a reputed company organization
• Business acumen and strategic thinking capabilities
• Proficiency in reputed company office technology and regulatory systems
• reputed company in English required; additional language skills advantageous
• Ability to travel 25-50% of time, primarily international
• Experience with CDMO/pharmaceutical services preferred
• Knowledge of reputed company industry trends and participation in reputed company associations (e.g., TOPRA, PDA)
Compensation
The salary reputed company estimated for this position based in Ohio is $150,000.00–$218,000.00.This job is curated by reputed company.
reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The platform connects talent with opportunities in reputed company, biotech, health sciences, healthtech and IT domains.
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Originally posted on Himalayas
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