10-03-2011 | EXPIRA LA 09-04-2011
Job expirat
Regulatory Affairs Officer - Job responsibilities:
• Managing efficiently all the new registrations/amendments/ approval process of the clinical trials and products submissions
• Provides support to the other departments, concerning launching plan, planning of variations, implementation of changes on the market, discontinuation of the marketed products.
• Ensures that the labeling, SmPC and leaflets are updated and accurate
• Manages the preparation of the specific Romanian packaging items, ensures that the approved texts are promptly sent to the plants and that the final validation is given in accordance with the approval obtained.
• Maintains accurate records of all ongoing/closed regulatory procedures.
• Provides supplementary information asked by the authorities in various phases of the register and/or renewal procedure.
• Provides support to the other members of the affiliate, concerning the drug regulatory aspects
• Maintains and develops good relationships with regulatory authorities and decision makers
CTA - Responsibilities:
- ensure administrative work of clinical trials: Create Investigator Files and other study information, booklets, worksheets, etc
- ensure timely translation and validation process of study materials (e.g. patient diaries, instructions, IC).
- provide investigators with all forms and lists to start the site evaluation and site validation (initiation and start of study information).
- handle databases
- establish a list of required documents
- maintain documentation up-to-date
- collect packages of documents
- prepare reports
- administrative tasks to assist team with clinical trial execution
- keep contacts with clients
- attendance at project team meetings
- prepare the ethical and regulatory submissions
- organize and documentation of local investigators meetings, finance administration
- archive the processes, including electronic documents and Trial Master File.
Regulatory Affairs Officer:
Education:
• Scientific background: Degree in Medicine, Pharmacy or Sciences
• Experience in drug control might be an advantage. Also certain certifications.
Experience & knowledge:
• At least two years experience within a pharmaceutical company or CRO in similar position; understanding of health care system and of the regulatory, legal and financial implications of the business
Skills:
• Good knowledge of current regulatory practice, laws and regulations in Romania and EU
• Wide scientific understanding and good understanding of pharmaceutical, medical, logistic and legal aspects
• Able to work as part of a team, and capable to build relationships across departments and functions
• Excellent communication and training skills
• Demonstrate flexibility, resilience and tenacity in complex and changing environment
• Able to take timely and effective decisions using innovation and initiative
• Use of database and published information/sources
• Computer literacy
• Fluency in English
CTA:
Skills and Experience:
- Ideally 1 - 2 years of administrative experience in international clinical research (EC submission; contract finalization); or similar
-Ability to multi task and prioritize work
-Fluent in Romanian & English – verbal and written
-Strong organizational and communication skills
- a high-school diploma,
- solid computer skills (proficiency in MS Word, Excel and PowerPoint),
- fluent spoken and written English is a MUST.
- good organizational and communication skills,
- attention to details
- accuracy in work.
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