Register Here to Apply for Jobs or Post Jobs. X

Director Cross Program Lead Regulatory Affairs US Vaccines

Job in Rockville - Montgomery County - MD Maryland - USA
Posted by Robsco Search
Full Time position
Listed on 2019-07-15
Job specializations:
  • Pharmaceutical
    Pharmaceutical Sciences
  • Science
    Biotech Clinical Research
Job Description & How to Apply Below
North America Regulatory Affairs (NARA) is a dynamic and growing part of Vaccines' Global Regulatory Affairs Organization. The Rockville, MD-based group of regulatory experts focuses on U.S.-licensed and developing-vaccine pipeline and provides advice on U.S. regulatory strategy for cutting-edge, novel vaccine technology while also delivering on post-marketing reporting requirements, regulatory filings in support of new applications, and liaising with the U.S. FDA and global product leads. The group’s leadership team members have diverse scientific backgrounds in virology, pharmacology, biochemistry, chemistry, and molecular biology, with decades of combined experience in drug development and vaccines.
·  The Role:
·  As a US Cross-Program Group Lead, within North America Regulatory Affairs, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US. The role provides US-focused strategic advice and executes on deliverables for US submissions and FDA interactions. The function has reporting requirements to the VP and Head of NARA and includes people and project/portfolio management benchmarked to key performance indicators aligned with the department and global objectives. Role will be part of the NARA leadership team (NARA LT) and share responsibility for overall US regulatory strategy and operations.
·  As a US Cross-Program Group Lead, Global Regulatory Affairs you will have the following responsibilities within a specific GRA project/portfolio within Vaccines:
·  • Cross portfolio aligned regulatory strategy to assure timely approvals for all US submissions.
·  • Facilitate integration of US-based individuals within portfolio group and integration of US-specific regulatory aspects into projects in general within the portfolio
·  • Ensure US-specific regulatory learnings are shared with the rest of the team, in line with culture of coaching
·  • Managerial responsibilities for US-based individuals within a specific GRA project/portfolio, consisting of resources overview and optimization at US GRA level, advice for US specific activities/processes, ensure appropriate training of US-based staff, and issue escalation:
·  • Management of US based staff within Portfolio
·  • Resources overview and optimisation of work distribution within Product/Project teams in agreement with GRL/RA RDC Head/NARA Head
·  • Cross portfolio resources support as appropriate
·  • Provide advice on US-specific activities and ways of working, processes as mentor or coach; in this role, provide support.
Position Requirements
Doctorate,   9 to 10 Years work experience
Contact Information
Contact Name: Robsco Search
Contact Phone: 5166588438
Preferred method of contact: Email with CV via Application Box below.
Apply for this Job Posting Here:
To apply for this job, you need to provide some contact details for the employer or HR recruiter. Begin your free application by entering your email address (If already registered, you'll be asked to enter your password). Otherwise, you will initially need to enter some basic details with your first application.
Email Address Please enter a valid Email address.
How this Free Jobsite works - How to apply for jobs.
• To apply for any job, you must provide some contact details for the employer or HR recruiter. When you Register Here or Above with your first application (if you have not already done so), you will be asked to confirm your contact email address is valid via your email inbox.
• You will be asked to confirm a login password so to be able to make further applications in future visits.
• Once registered, you may also save CV / Resume summary details into the optional Resume format (This default format is easy for companies to read, and when available, it is sent as part of your application to a company to assist your application).
• Alternatively or additionally, you may attach your own original Resume document and 2 other supporting files as part of your application (Those files must be within the maximum combined size stated, and are not stored on this jobsite when you submit them).
• You must write or paste an introduction / cover letter into the application box.
• When you click the "Apply" button, your cover letter, Resume summary (if you have saved one on this site), contact details, and/or your own attached files are submitted as part of your application.
• Once you submit an application for any job on this site, it is solely the responsibility and decision of the company or employer you have applied to on whether they accept, review, process or respond to that application.
Search for further Jobs Here:
(Enter less keywords for more results. Suggestions may be selected)
Employment Category
Education (minimum level)
Education Level
Experience Level (years)
Posted in last:
LOGIN Area - Jobsite