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Job Details

Manager/Associate Director, Regulatory Affairs

Company: RBW Consulting
Location: Princeton, NJ
Reference: RA-MADRA-PNJ
Closing Date: 14 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at (646) 586 9087 today!

Requirements:

Manager or Associate Director, Regulatory Affairs 

Princeton, NJ

Major Accountabilities: 

  • Ensures the overall regulatory strategy aligns with the target product profile (TPP), US specific needs, US biosimilar regulatory environment, and global development strategy for assigned projects
  • Represents US BRA as a member of the cross functional project team to provide regulatory guidance throughout the research, development, launch and post-approval process. Acts as the single point of contact for the business on US regulatory issues for assigned projects. Interacts with key scientific, clinical research, and commercial personnel within and outside the company to ensure timely and accurate regulatory compliance
  • Identifies and assesses regulatory risks associated with product development. Defines strategies to mitigate risks. 
  • Acts as a FDA liaison contact for project issues. Leads FDA project meetings and major label negotiations with FDA
  • Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects and programs, including IND, BLA, product line extension application, change control supplements and labelling supplements
  • Reviews reports from contributing functions and provides comments to assure accurate and complete documents for FDA submissions
  • Coordinates and supervises the development of regulatory strategies for new medical devices as part of combinational product registration for injectable biologics
  • Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to bio-similar products and understand the impact on current and future submissions 
  • Leads work plans and provides regulatory affairs direction to lower-level resources. Creates schedules and work plans for monitoring, compiling and submitting filings that are consistent with company standards. Often plays a proactive role in developing and applying new approaches to tracking data and submitting filings
  • Participates in the modification, development and implementation of company policies and practices for regulatory affairs that affect subordinate resources
  • Directs the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities. Responsible for implementing operation- al and strategic policies and directives. Develops functional processes for area man- aged
  • Interfaces with senior management to report on project and program milestones and 
  • to present project needs. Requires the ability to influence others to achieve results. Assignments are given in the form of objectives with no process defined. May or may not manage lower-level supervisors

Supervisory:

  • May manage junior employees; Supervises junior regulatory staff with the planning, preparation and submission of regulatory documentation

Key Performances: 

  • Ability to translate over-arching goals into specific objectives and strategies to meet these objectives
  • Demonstrates a track record of successful interaction with FDA, as manifested by successful and timely submissions and approvals of bio-similar products. 
  • Build and maintain excellent relationships with FDA. Utilizes familiarity with the intricacies and nuances of different review divisions within FDA, as well as the decision- makers within the agencies
  • Successful interactions with R&D and commercial leadership teams. Diverse and sufficient technical expertise to be a credible interface to all development and business partners (CMC, preclinical, clinical, statistician, sales and marketing, legal, etc.). Able to lead and influence cross functional teams, committees to attain group goals
  • Demonstrates in-depth working knowledge in interpreting regulations, guidelines, guidance, policy statements. Applies regulatory and therapeutic area knowledge to commercial team’s objectives and initiatives for developing vision and solutions for effective communication
  • Assignments are received in task and objective oriented terms. Provides direction to subordinates based on general policies and management guidance. Work is reviewed upon completion for adequacy in meeting objectives
  • Interprets and executes policies and procedures that typically affect subordinate organizational units. Recommends modifications to operating policies
  • Functions as an advisor to a unit regarding tasks, projects, and operations. Becomes actively involved in daily operations only when required to meet schedules or to resolve complex problems. 
  • Ensures that projects are completed on schedule and within budget. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure or additional time, human resources, and funds
  • Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Conducts briefings and participates in technical meetings for internal and external representatives concerning specific operations


Education: 

  • Bachelor's Degree required 
  • PhD, PharmD or MS in Biology or Chemistry preferred 


Experience: 

  • 8+ years of professional related experience including a minimum of 7 years of relevant regulatory experience preferred. Experience in CMC regulatory and biologics preferred.

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at (646) 586 9087 today!

Apply for this job: Manager/Associate Director, Regulatory Affairs

Contact Information:

Address:  US Team
Origin Two 106 High Street, Crawley
RH10 1BF
England
Tel:  (646) 586 9087
Website:  Visit Our Web Site

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