• Company:
  MedFocus Pharmaceutical Research Opportunities
• Location:
  Chesterbrook, PA 19087
• Status:
  Full Time
  Temporary/Contract/Project
• Education:
  Bachelor's Degree
• Industries:
  Biotechnology/Pharmaceuticals
• Occupations:
  Biological/Chemical Research
  Clinical Research
  Pharmaceutical Research
• Work Experience:
  7+ to 10 Years
• Job Category:
  Biotech/R&D/Science
• Career Level:
  Manager (Manager/Supervisor of Staff)
• Contact:
  Tom Briscoe
• Email:
  Apply by Email
• Reference Code:
  0000070149

Since 1993, MedFocus has succeeded in meeting the contract staffing needs of our consultants and clients faster and more effectively than our competition through "specialized" recruiting exclusively in the pharmaceutical arena. By staying focused, MedFocus has become the firm of choice for both client companies and our consultant job seekers.

Sr. Regulatory Affairs Manager

REGULATORY AFFAIRS MANAGER/SENIOR MANAGER COMPANY INFO: MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel. Our client focuses its business on attention deficit and hyperactivity disorder, human genetic therapies and gastrointestinal diseases and is seeking to add a Regulatory Affairs Manager/Senior Manager to their team in Chesterbrook, PA. RESPONSIBILITIES: •    Offers strategic and operational regulatory support to preclinical, clinical, manufacturing, quality assurance and marketing departments. •    In collaboration with management, develops and reviews regulatory strategy for operational efficiency. •    Negotiates and makes agreements on behalf of the department. •    Interprets applicable regulations and guidelines for project team use.  Keeps project team abreast of regulatory decisions, issues, potential problems and new regulations. •    Provide regulatory review of promotional materials and ensure compliance with federal regulations and corporate SOPs. •    Responsible for investigational and post-approval submissions associated project, including safety reporting, CMC, and labeling responsibilities. •    Ensures timely submission of appropriate regulatory documents individually, as a regulatory team, or through contract organizations. •    Coordinates and solicits components of the submission from various functional areas. •    Raises major project issues to management for resolution and agreement.   •    Work efficiently and effectively within regulatory team, fostering collaborative exchanges, teamwork, and mentoring of colleagues. •    Attends company advisory panel meetings, investigator meetings and kick-off meetings as required. •    Mentors other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff. •    Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses. •    Complexity and Problem Solving •    Decisions on regulatory strategy are to be made by this individual.  Decisions of significant strategic impact must be discussed to supervisor. •    Position is accountable to supervisor.  Internal contacts may include PST members, BU representatives, R&D functional representatives, Legal, Supply Chain, and Program Management.  External contacts may include health authorities, vendors, and consultants retained by company •    Some domestic and potential international travel required. QUALIFICATIONS: •    Bachelor’s degree is required. Scientific/health care field preferred, but not required. •    Generally has at least 7 years of related experience within a pharmaceutical company, CRO or similar organization and at least 2 years of management experience; or equivalent combination of education and experience.   •    Generally has at least 4 years direct regulatory affairs experience. •    Must have experience in drug promotional review, including consumer and professional venues. •    Must be able to communicate comfortably and effectively with regulatory authorities. •    Must have extensive experience effectively working in team environment. •    Ability to work successfully within a cross-functional team. •    Must be able to independently present complex information to copmany senior management, CROs, regulatory authorities and the medical community. •    Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.   •    Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands. •    Ability to work independently, take initiative and complete tasks to deadlines. •    Proven ability to independently resolve problems. •    Strong knowledge of MS Word, Excel, PowerPoint, Project and Outlook. MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.