Senior Director, Regulatory Services Management (RSM) at Certara
Remote, Oregon, USA -
Full Time


Start Date

Immediate

Expiry Date

15 Nov, 25

Salary

0.0

Posted On

15 Aug, 25

Experience

8 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Strategy, Global Teams, Collaboration, New Opportunities, Color, Technology, Drug Development, Ethnicity, Training, Customer Value, Regulatory Requirements, Leadership Skills

Industry

Other Industry

Description

4. CLIENT EXPERIENCE



    • Able to identify new opportunities and leverage Certara talent and technology to expand business offerings, strengthen and expand ongoing client relationships, and create new ones

    • Ensures that integrated business processes lead to increased client satisfaction and repeat business
    • Monitors and participates in overall direction, strategy and performance standards for Project Managers/Project Directors/project teams
    • Ensures services provided to clients are compliant with company policies, procedures, SOPs, ICH-GCPs, client contractual expectations and country specific regulatory requirements
    • Coordinates with senior management to assure projects are meeting corporate and client objectives
      Qualifications:

    SKILLS & ABILITIES:

    • Recognizes key contacts within the regulatory community and finds ways to make exclusive connections
    • Monitors competitors and their strategies and recommends appropriate actions internally to maintain competitive position. Identifies external best practice, adapting knowledge to work. Works to achieve internal and external credibility regarding industry knowledge.
    • Is self-motivated and solution-driven
    • Will confront unfamiliar situations with confidence and optimism, both technical and interpersonal
    • Promotes a culture of open communication and respect in a fast-paced, changing environment
    • Provides individuals with development opportunities to test their capabilities and achieve higher levels of performance, but is also a team player who enjoys collaboration

    EDUCATION, EXPERIENCE, TRAINING, AND KNOWLEDGE:

    • 10+ years of relevant experience and MS degree or better preferred
    • Minimum of 8+ years of experience in a regulatory affairs area within the biopharmaceutical industry or a Contract Research Organization (CRO) environment
    • Add customer value by demonstrating extensive knowledge of the drug development and regulatory submissions process
    • Ability to lead global teams and effectively manage staff across multiple projects
    • Demonstrated leadership skills growing and developing a team
      Certara bases all employment-related decisions on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
    Responsibilities

    Please refer the Job description for details

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