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СА ИНФИНИТИ ЕУРОПЕ ДООЕЛ
S.A. INFINITY EUROPE is seeking a highly qualified:
Regulatory Affairs Officer
Support the timely compilation of site documentation for global regulatory submissions.
Compilation of CTD files or other as required is essential;
Keeping up to date with international legislation, guidelines and customerpractices in all countries that the company is exporting to;
Collecting, collating and evaluating scientific data that has been researched by colleagues;
Developing and writing clear arguments and explanations for new product authorizations;
Preparing submissions of authorization variations and renewals to strict deadlines;
Monitoring and setting timelines for variations and renewal approvals;
Working with specialist computer software and resources;
Writing clear, accessible product labels and patient information leaflets;
Planning and developing product trials and interpreting trial data;
Advising scientists and manufacturers on regulatory requirements;
Providing strategic advice to senior management throughout the development of a new product;
Project managing teams of colleagues involved with the development ofnew products;
Undertaking and managing regulatory inspections;
Reviewing company practices and providing advice on changes to systems;
Laising with, and making presentations to, regulatory authorities;
Negotiating with regulatory authorities for marketing authorization;
Specifying storage, labeling and packaging requirements;
Co-ordinate requests for legalization of GMP, ML, PoA and other documents.
Interact with global Regulatory partners, internal cross functional teams, and consultants.
Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
Ensure consistent and appropriate communication within the department and with other functional areas.
Assist in the preparation for on-site inspections by global regulatory authorities.
Participate in cross-functional project teams and work effectively with multiple disciplines and personalities.
Plan, contribute, evaluate and deliver on the needs of various projects
Build respect and trust with customers, both internally and externally, to establish effective and influential working relations
Develop high level of personal quality and embrace right first time culture
Actively contribute to continuous improvement opportunities ensuring compliance and best value can be achieved
Develop technical expertise in the field, specific product (processes) areas and keep abreast with own area of expertise
Assessment of product risk complexities, product safety and effectiveness
Coordinates and facilitates submissions making best use of knowledge and expertise across departments and lessons learnt and communicate effectively with key stakeholders
Educates and shares information and coaches others on regulatory expectations
Be open and contribute towards improvements / changing expectations
Strive for simple and effective solutions
Be supportive and self-reliant; be able to act and function independently whilst interacting effectively with others collaboratively
Be realistic on capacity; plan and deliver on promises.
Support cross-training opportunities & skills.
Analyse working practices and offer flexibility where needed to deliver.
Other tasks by order of the manager or director
Bachelor of Sciences (BSc) degree, or higher in a relevant scientific area (pharmacy, medicine or biochemistry sciences) or other regulated manufacturing environment, experience in developing and implementing quality management systems.
At least 3 years relevant experience in a pharmaceutical company
Language: English excellent
An awareness of current development and manufacturing processes, differing product complexities, risk classification and stability are also an advantage.
Sound understanding and awareness of regulations and expectations globally
Candidate should demonstrate initiative and have the ability to work both independently and collaboratively in a team structure.
Demonstrated effective problem solving, strong time management skills and the ability to prioritize multiple tasks are also required.
Interested candidates are kindly requested to send their updated CVs using the Fast Apply option.
Note: only shortlisted candidates will be notified.
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