Regulatory Affairs Manager (maternity leave replacement)
Job Description
REGULATORY AFFAIRS MANAGER
OVERALL RESPONSIBILITY:
Management of the new registrations, license maintenance and related activities for the assigned products under the supervision of the Head of Regulatory Affairs Group. Be accountable for the regulatory compliance within the area of responsibilities. Provision of regulatory advice to and liaison with key customers (internal/external).
MAIN RESPONSIBILITIES:
Collate, coordinate and, where required, create the necessary technical data to support the submission of new MA applications, renewals and variations for the assigned products in accordance with the local legislation
Inform the relevant internal stakeholders, according to global and local policies and procedures, about the regulatory authority’s approval of changes to the packaging component(s) for the assigned products to ensure their timely and accurate implementation.
Keep updated the local registration tracking of all new/ongoing applications, renewals and variations for the assigned products, and corresponding related databases/systems.
Contribution in managing Pfizer’s relationship with the authorities, external experts and others involved in the regulatory review and decision processes.
PROFESSIONAL REQUIREMENTS:
University Degree in a field of chemistry/pharmacy/medicine
At least 2 years’ experience in registering medical products is required
Knowledge of Ukrainian legislation and requirements in registering medical products and medical devices
Proven ability to manage complex regulatory issues.
Technical Skill Requirements:
Technical
High level of proficiency in both Ukranian and English (written and spoken).
Ability to interpret and relay technical information.
Very good time management.
Proficiency with computer and software applications (i.e. Microsoft Office).
Managerial
Demonstrates keen analytical skills and attention to detail.
Good communication skills, ability to work in team
Able to work in a fast-paced environment with competing priorities.
Ability to work independently as well as part of a team.
Proactive and ready to take new challenges
Reporting line:
Regulatory Affairs Manager has a solid reporting line to the Head of Regulatory Affairs Ukraine.
LAST DAY TO APPLY: JULY 24th 2024
Нашацель-Передовыерешения,меняющиежизнипациентов
Pfizer –этокомпания,ориентированнаянапациентов, и всвоейдеятельностимыруководствуемсячетырьмяценностями:смелостью,радостью,справедливостьюисовершенством.Культурапередовыхрешенийпомогаетнамвстремленииизменитьклучшемужизнимиллионовпациентов.
СотрудникиPfizerразныхстрантрудятсявместе,чтобывнестисвойвкладвулучшениездоровьялюдейвовсеммире.Мыпостоянноработаемнадразработкойинновационнойтерапиииищемновыевозможностидляразвития,находясьвнепрерывныхпоискахновыхталантов.
Гибкаяикомфортнаярабочаясреда
Мыстремимсясоздаватькомфортнуюигибкуюрабочуюсреду,котораяприветствуетсоблюдениебалансаработыиличнойжизниколлег,привлекаетталантыипозволяеткаждомусотрудникураскрытьсвойпотенциал.Мызаоткрытыйдиалог!
Равнаявозможностьтрудоустройства
Мыуверены,чторазнообразнаяиинклюзивнаярабочаясредаимеетрешающеезначениедлядостиженияуспеховвбизнесе.Какработодатель, Pfizerстремитсяподдерживатьпринципразнообразия,предоставляясотрудникамвозможностьбытьтакимижеразными,какпациентыисообщества,радикоторыхмыработаем.Вместемыформируемкультуру,котораявдохновляет,поддерживаетиразвиваетнашихсотрудников.
Purpose - Breakthroughs that change patients' lives...
At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Pfizer colleagues in different countries work together to improve the health of people all over the world. We are constantly working on the development of innovative therapies and growth opportunities, being in continuous search of new talents.
Flexible Work Environment
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
