Senior Registration Specialist
Job Description
Why Patients Need You
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
What You Will Achieve
Reliable documentation services form an essential component of a well-run Regulatory Affairs department. You will be the one entrusted with managing an efficient documentation system, record retention, and information services in compliance with regulatory requirements. You will ensure that procedures are in place to maintain records and interpret all documentation standards, policies, and operating procedure requirements. You will identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. You will maintain knowledge of product information and continuous contacts with local, regional, and divisional customers.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and dedication that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- 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 for the assigned products to ensure their timely and accurate implementation.
- Provide guidance and supervise tender operations team in preparing tender document, particularly on technical aspects such as product specifications, certificate of analysis to ensure meeting customer requirements.
- Analyze tender reports prepared by the distributor and prepare for discussion with key stakeholders to improve tender operations and meet business needs.
- Review all the documents and dossiers related to submissions of new product registration, line extensions, post-approval changes and License Renewals, ensuring that dossiers to be submitted fully meet the local regulatory requirements.
- Support the Regulatory Affairs Lead/ Senior Regulatory Affairs Manager/ Regulatory Affairs Manager in the timely preparation of reports, such as the Monthly Operating Report.
- Perform data entry and quality control tasks associated in all global regulatory systems impacted, including systems associated with the regulatory data scope.
- Keep the Safety team informed of adverse events according to relevant Standard Operating Procedures (SOPs).
- Liaise with clinical research project managers to seek to understand clinical research program.
- Provide professional comments, recommendations, and information on relevant regulations to local colleagues.
Qualifications
Must-Have
- Bachelor's Degree
- 3+ years of demonstrated experience in Regulatory Affairs or related function within pharmaceutical sector
- Proven ability to oversee and provide Quality Control support for others’ work
- Knowledge of National and Clinical Trials legislation, and guidelines
- Ability to interpret and relay technical information, work with accuracy and provide attention to detail
- Ability to work independently as well as part of a team
- Proficiency in English, verbal and written
- Proficiency with computer and software applications
Nice-to-Have
- Master's degree
- Relevant pharmaceutical experience
Work Location Assignment: Flexible
Наша цель - Передовые решения, меняющие жизни пациентов
Pfizer – это компания, ориентированная на пациентов, и в своей деятельности мы руководствуемся четырьмя ценностями: смелостью, радостью, справедливостью и совершенством. Культура передовых решений помогает нам в стремлении изменить к лучшему жизни миллионов пациентов.
Сотрудники Pfizer разных стран трудятся вместе, чтобы внести свой вклад в улучшение здоровья людей во всем мире. Мы постоянно работаем над разработкой инновационной терапии и ищем новые возможности для развития, находясь в непрерывных поисках новых талантов.
Гибкая и комфортная рабочая среда
Мы стремимся создавать комфортную и гибкую рабочую среду, которая приветствует соблюдение баланса работы и личной жизни коллег, привлекает таланты и позволяет каждому сотруднику раскрыть свой потенциал. Мы за открытый диалог!
Равная возможность трудоустройства
Мы уверены, что разнообразная и инклюзивная рабочая среда имеет решающее значение для достижения успехов в бизнесе. Как работодатель, Pfizer стремится поддерживать принцип разнообразия, предоставляя сотрудникам возможность быть такими же разными, как пациенты и сообщества, ради которых мы работаем. Вместе мы формируем культуру, которая вдохновляет, поддерживает и развивает наших сотрудников.
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.
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