Manager, Regulatory Affairs

San Francisco, CA

Perm Salary

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Manager, Regulatory Affairs. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Responsible for supporting the Regulatory department across a number of company-sponsored projects
  • Primarily responsible for assembling and reviewing regulatory dossiers prior to review by senior regulatory management
  • May select, develop, and evaluate personnel to ensure the efficient operation of the function
  • Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals
  • Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends
  • Follows processes and operational policies in selecting methods and techniques for obtaining solutions
  • Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems
  • Supports regulatory filings and registrations by coordinating, assembling, preparing and editing for review regulatory document packages in support of investigational and new device and/or drug applications, and post-approval submissions, for US and ROW (e.g., 510(K), IDE, IND, NDA, CTD, CTA, IMPD, MAA, Drug/ Device Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc.) 
  • Prepares information for, review and ensures that submissions meet format and content requirements applicable for regulatory requirements (i.e., US, ICH)
  • Reviews specifications, methods, SOPs, protocols, reports, labeling, and etc. for regulatory compliance
  • Maintain regulatory submissions and correspondence for company-sponsored projects, and all company-related sections for partner-sponsored projects
  • Drafts and reviews Regulatory Affairs' SOPs. May participate in, and provide regulatory guidance to working teams (both internal and partnered programs)

EXPERIENCE

  • Minimum eight years' industry experience is required
  • Minimum six years' experience in the pharmaceutical or other related industry
  • Minimum four years' hands-on Regulatory Affairs experience, in either drugs and/or medical devices
  • Minimum five years' previous management experience
  • Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills
  • Must be detail- and goal-oriented, quality conscientious, and customer-focused
  • Must be able to adhere to strict project timelines
  • Experience in working in a multi-disciplinary team environment
  • Ability to adapt to changing priorities and to manage multiple tasks
  • Strong computer skills in Word, Excel and Adobe Acrobat, and working knowledge of electronic publishing/file management systems are an asset
  • Ability to use Internet for research applications
  • Expected to maintain current awareness of US, and knowledge of ROW regulatory requirements, guidelines and regulations (i.e., cGXP)

EDUCATION

  • A minimum of a Bachelors degree in a scientific discipline is required

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource  

About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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