Regulatory Affairs Clinical Trial Application

hace 1 semana

Buenos Aires, Argentina Pfizer A tiempo completo

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. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. This is a multifaceted role that will offer you a number of opportunities to enhance your skills. Your focus and ability to meet the team’s 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 make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It- Prepares documentation and materials needed for the submission and maintenance of new CTA´s or changes in approved Clinical Trials for the National BoH and/or National Registries.- Ensure timely communication of any GCP breaches, or actions taken for safety reasons.- Coordinate the activities related to CTAs and maintenance to Health authorities.
- Support the review of CTA submission ready dossiers is done, ensuring that submissions fully meet the local regulatory requirements, and provide the necessary information to ensure internal systems and databases are updated. This includes BoH query response.
- Complete departmental training in a timely manner to address corporate and regulatory needs.
- As applicable, contribute to local regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation.

**Qualifications**:
Must-Have
- Bachelor's Degree
- 3+ years of demonstrated experience in regulatory affairs or in a regulated industry
- Proven ability to manage complex regulatory issues and consistently deliver to time and quality standards
- In-depth knowledge of the current health regulatory framework
- Problem solving skills, strong detail, quality and compliance orientation
- Good verbal and written communication skills and fluent in English
- Proficient computer skills, e.g. MS Office, MS Outlook, Internet, database use

Nice-to-Have
- Relevant pharmaceutical experience
- Strategic thinking with good project management skills

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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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