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Regulatory Affairs Officer/Manager 0,5 FTE
PFIZER LUXEMBOURG SARL, organizačná zložka
Place of work
Tower 115, Pribinova 25, Bratislava
Tower 115, Pribinova 25, Bratislava
Contract type
part-time, agreement-based (Temporary jobs)
part-time, agreement-based (Temporary jobs)
Start date
by agreement
by agreement
Basic wage component (gross) and other rewards
by agreement
by agreement
Information about the position
Job description, responsibilities and duties
This is what you can look forward to:
• Liaise with clinical research project managers to seek to understand clinical research programme.
• In partnership with above-country operational hubs, above-country WSR strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority (RA) queries.
• Interaction with Local RA for CTAs.
• Accountable for the regulatory compliance within CTA responsibilities.
• New Marketing Authorisation Application (MAA) in Centralised procedure, MRP/DCP, National procedure.
• License maintenance and related activities for the assigned Marketing Authorisations.
• Development of the Artworks for marketed medicines under the supervision of the Head of Regulatory Affairs. Accountable for the regulatory compliance within the area of responsibilities.
• Interaction with Local Regulatory Authority for allocated MAs.
• Liaise with clinical research project managers to seek to understand clinical research programme.
• In partnership with above-country operational hubs, above-country WSR strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority (RA) queries.
• Interaction with Local RA for CTAs.
• Accountable for the regulatory compliance within CTA responsibilities.
• New Marketing Authorisation Application (MAA) in Centralised procedure, MRP/DCP, National procedure.
• License maintenance and related activities for the assigned Marketing Authorisations.
• Development of the Artworks for marketed medicines under the supervision of the Head of Regulatory Affairs. Accountable for the regulatory compliance within the area of responsibilities.
• Interaction with Local Regulatory Authority for allocated MAs.
Requirements for the employee
Candidates with education suit the position
University student
University education (Bachelor's degree)
University education (Master's degree)
University education (Bachelor's degree)
University education (Master's degree)
Language skills
English - Upper intermediate (B2) and Slovak - Proficiency (C2)
Number of years of experience
2
Personality requirements and skills
What you offer:
• Scientific Degree in Natural Sciences, Pharmacy / Medicine or equivalent suitable scientific background
• Minimum 2-3 years of professional experience in Regulatory Clinical Trial Applications
• Minimum 2-3 years of experience in Regulatory Affairs in the pharmaceutical industry
• Proven ability to manage Clinical Trial Applications
• Fluency in oral and written English
• Excellent communication and interpersonal skills
• Well organized
We offer a job contract for 0,5 FTE via external personnel agency. In addition to competitive salaries and customized benefits packages, we also offer a supportive and diverse culture, work in international environment and unparalleled career development opportunities.
• Scientific Degree in Natural Sciences, Pharmacy / Medicine or equivalent suitable scientific background
• Minimum 2-3 years of professional experience in Regulatory Clinical Trial Applications
• Minimum 2-3 years of experience in Regulatory Affairs in the pharmaceutical industry
• Proven ability to manage Clinical Trial Applications
• Fluency in oral and written English
• Excellent communication and interpersonal skills
• Well organized
We offer a job contract for 0,5 FTE via external personnel agency. In addition to competitive salaries and customized benefits packages, we also offer a supportive and diverse culture, work in international environment and unparalleled career development opportunities.
Advertiser
Brief description of the company
Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Number of employees
50-99 employees
Company address
ID: 2553211 Dátum zverejnenia: 10.4.2018 Lokalita: Tower 115, Pribinova 25, Bratislava Pozícia: Clinical Data Manager, Clinical Research Associate, Drug Safety Specialist, Regulatory Affairs Specialist Spoločnosť: PFIZER LUXEMBOURG SARL, organizačná zložka Základná zložka mzdy (brutto) a ďalšie odmeny: by agreement