Manager Global Regulatory Development

Cambridge, MA

Contract

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OVERVIEW

Now hiring for a hungry Manager Global Regulatory Development who has a generous spirit, is committed to creating change and is committed to the pharmaceutical industry. The Manager Global Regulatory Development role is located in Cambridge, Masachusetts and will plan, manage and execute all regulatory activities of all levels of complexity for project of responsibility in development and supports regulatory activities for assigned marketed product of responsibility with regards to compliance to Competent Authority regulations.

RESPONSIBILITIES

  • Collaborates with all regions to ensure a global regulatory strategy is created and executed upon for all projects within project of responsibility 
  • Working with global lead (GRL and GSM) as needed in leading the regulatory working team (SWG) and represents regulatory at CTWG
  • Ensures global regulatory strategy is written and executed according to plan for assigned projects 
  • Manage all relevant submissions and approvals for project(s) of responsibility 
  • Accountable for ensuring all other regulatory submissions outside of region are submitted on schedule by local affiliates within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy 
  • Responsible for achieving submission of INDs, CTAs, briefing packages, responses, and other submissions
  • Keeps Medical, CMC and Regulatory Affairs employees abreast of changes to regulations and the impact on corresponding procedures 
  • May develop or author for less complex programs or assist Global Regulatory Lead with development of global regulatory strategy 
  • Direct point of contact with health authorities on general issues
  • As assigned, is responsible for due diligence activities for evaluation of possible in-licensing compounds in area of therapeutic responsibility 

EXPERIENCE

  • Two or more years of pharmaceutical industry experience, inclusive of reasonable regulatory experience or combination of moderate regulatory or related experience 

EDUCATION 

  • Bachelors or Masters of Science preferred, Bachelors of Arts accepted

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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