Post by abarcelo on Sept 14, 2015 14:20:29 GMT
Regulatory Specialist, Global Regulatory Therapeutic Area (TA) (99383)
• 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:
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.
To support, manage and provide follow-up on the preparation of regulatory documentation for submission to regulatory agencies
KEY TASKS & RESPONSIBILITIES
• Processes submissions of applications for clinical trials and new marketing authorizations for pharmaceutical products and submissions of renewals and variations during the lifecycle of the products Provides dossiers for new applications, amendments, variations, renewals and answers to questions of authorities to affiliates/local regulatory partners
• Provides CTA Core Master Documents to local regulatory partners in cooperation with TA responsible and GRO.
• Prepares and fills application forms in close cooperation with the TA responsible and affiliates/local regulatory partners.
• Keeps close contact to the affiliates/local regulatory partners for exchange of regulatory requests and information regarding the allocated tasks
• As need bases, may enter and maintain data into respective databases for regulatory status, planning activities, and publishing
• Coordinates the provision of requests from affiliates/local regulatory partners to the responsible internal functions, prepares the document for answers to objections in the relevant document management system and administratively finalizes submission packages in this system in close cooperation with the TA responsible.
• May contribute to review of regulatory quality documents
MAIN INTERFACES (ranked by order of importance)
INTERNALLY:
Other Global Regulatory functions
Global Development functions
Research functions
Portfolio and Business Development functions
Commercial Europe, US, Japan and others
Global Marketing functions
EXTERNALLY:
Local Regulatory Affairs in ICH countries
CANDIDATE’S PROFILE
EDUCATION/LANGUAGES
Degree in a Life Science
Master degree in Regulatory affairs will be appreciated or minimum two years’ experience in Regulatory Affairs environment
• Excellent spoken and written English, and a second language would be an asset.
PROFESSIONAL SKILLS & EXPERIENCE
• Proven ability to handle software and databases needed to support the regulatory function according to the role.
PERSONAL SKILLS & COMPETENCIES
• Excellent communication skills
• Excellent interpersonal skills
• Attention to details
• Good teamwork skills
Please send your resume and your cover letter to m2ipil-english.freeforums.net/
• 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:
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.
To support, manage and provide follow-up on the preparation of regulatory documentation for submission to regulatory agencies
KEY TASKS & RESPONSIBILITIES
• Processes submissions of applications for clinical trials and new marketing authorizations for pharmaceutical products and submissions of renewals and variations during the lifecycle of the products Provides dossiers for new applications, amendments, variations, renewals and answers to questions of authorities to affiliates/local regulatory partners
• Provides CTA Core Master Documents to local regulatory partners in cooperation with TA responsible and GRO.
• Prepares and fills application forms in close cooperation with the TA responsible and affiliates/local regulatory partners.
• Keeps close contact to the affiliates/local regulatory partners for exchange of regulatory requests and information regarding the allocated tasks
• As need bases, may enter and maintain data into respective databases for regulatory status, planning activities, and publishing
• Coordinates the provision of requests from affiliates/local regulatory partners to the responsible internal functions, prepares the document for answers to objections in the relevant document management system and administratively finalizes submission packages in this system in close cooperation with the TA responsible.
• May contribute to review of regulatory quality documents
MAIN INTERFACES (ranked by order of importance)
INTERNALLY:
Other Global Regulatory functions
Global Development functions
Research functions
Portfolio and Business Development functions
Commercial Europe, US, Japan and others
Global Marketing functions
EXTERNALLY:
Local Regulatory Affairs in ICH countries
CANDIDATE’S PROFILE
EDUCATION/LANGUAGES
Degree in a Life Science
Master degree in Regulatory affairs will be appreciated or minimum two years’ experience in Regulatory Affairs environment
• Excellent spoken and written English, and a second language would be an asset.
PROFESSIONAL SKILLS & EXPERIENCE
• Proven ability to handle software and databases needed to support the regulatory function according to the role.
PERSONAL SKILLS & COMPETENCIES
• Excellent communication skills
• Excellent interpersonal skills
• Attention to details
• Good teamwork skills
Please send your resume and your cover letter to m2ipil-english.freeforums.net/