Post by abarcelo on Sept 14, 2015 14:25:33 GMT
Manager, Global Regulatory Affairs Project Support (84744)
• Company:
Merck Serono
• Location:
Billerica, Massachussetts, US
• Job Status/Type:
Full Time, Employee
• Job Category:
Biotech/ R&D/ Science
• Occupation:
Pharmaceutical Research
• Industry:
Biotechnology/ Pharmaceuticals
• Work Experience:
2 to 5 years experience
• Education Level:
Higher Degree in Life science
• Date of publication : 09/14/2015
COMPANY PROFILE
EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.
Your primary responsibility will be to provide statistical leadership for clinical development projects throughout the whole drug development life cycle.
PURPOSE OF THE ROLE
Global Regulatory Affairs is actively involved in the development and life-cycle management of medicinal products thereby contributing to appropriateness of the drug development path as well as to compliance with applicable pharmaceutical legislation / regulation.
The purpose of the regulatory affairs support is to assist the Global regulatory lead and/or the Regional lead in preparation and execution of global regulatory strategies and to manage the submission and approval of applications for clinical trials, marketing applications or other related regulatory submissions (orphan designation, annual report, pediatric plans etc.)
KEY TASKS & RESPONSIBILITIES
• Manage the regulatory submission including management and coordination of the preparation of all regulatory documentations at different Regulatory milestones
• Manage of the regulatory agency interactions, document preparation (under supervision of a Therapeutic Area Head or Regulatory Strategist)
• Contribute to development and evaluation of regulatory strategies for projects (under supervision of the Regulatory Strategist )
• Review and provide regulatory comments to quality-, safety- and efficacy or labeling related documents (e.g. protocols, reports) to be included in a regulatory submission (e.g. Clinical Trial Applications, IND, Scientific Advice, HA interactions, Answers to Authorities)
• Contribute to the development of risk assessment pertaining to the quality-, safety- and efficacy documentation/data of investigational medicinal products related applications.
CANDIDATE’S PROFILE
EDUCATION/LANGUAGES
• Degree in Life Science or related discipline, higher degree preferable (Pharm.D., MSc, PhD, MBA)
• Excellent spoken and written English
PROFESSIONAL SKILLS & EXPERIENCE
• Minimum of 2 years’ industry experience of which at least 1 years’ regulatory experience
• Experience with preparation and writing regulatory documentation to support agency interactions
• Experience in IND / CTA / eCTD requirements
• Knowledge of international regulatory affairs
• Experience with maintenance of regulatory authorizations in at least one region
• Experience with supporting a project with development activities in at least one region
PERSONAL SKILLS & COMPETENCIES
• Excellent written and spoken communication skills
• Good interpersonal skills
• Attention to detail
• Ability to work in teams
• Strong organizational and planning skills
Please send your resume and your cover letter to m2ipil-english.freeforums.net/