Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist

Alternative job title:

Job location: Bucharest, RO

Experience requirements: No experience

Workfield requirements: Chemistry, Physics & Biology

Contract type: Permanent full-time

Sector: Pharmaceutical Sector

Locations: Romania - Bucuresti-Ilfov

Description

• Preparation of Marketing Authorization (MA) applications, renewals, variations and related activities
• 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, ensuring that their presentation and the contents comply with the required format.
• Support the European wide application process for the assigned products, clarifying the requirements and ensuring local needs are met.
• 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.
• Link with the Product Quality Manager for timely implementation of the approved labelling-associated artworks.
• Follow-up of outstanding applications and queries with business focus
• Monitor the progress of applications against the set timelines, taking action when necessary (taking account of application) to minimize delays and any anticipated difficulties.

• Handling with all relevant global databases and systems and other applications, as appropriate.
• Keep updated the local registration tracking of all new/ongoing applications, renewals and variations for the assigned products, and corresponding related databases/systems.

• Provide accurate, consistent, timely and balanced responses to the Regulatory inquiries on the assigned products raised by relevant internal stakeholders.
• Upon request of the local Product Quality Manager, play an active role in product quality issues actions in order to minimize the impact on business.
• Attend relevant meetings across Pfizer providing guidance as necessary to support the development of regulatory activities and strategies.

• Demonstrate value proposition of quality and compliance to internal and external stakeholders.
• Apply a risk management approach.

• Provide support for all audits under Medical Director / Platform Head (Regulatory/Safety) Accountability, including audit corrective and preventive action plans (CAPAs).

Offer

competitive salary rate and social package

wide opportunities for professional development

Required profile

• Life science, medical science, pharmaceutical or chemistry graduate (Master's degree).

• 5+ years of Pharmaceutical Regulatory experience
• Proven ability to consistently deliver to time, cost and quality standards.
• Understanding of National, EU and ICH directives and regulation
• Industry experience in Regulatory Affairs and/or Clinical Trial Management
• Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation
• Strong problem solving skills and team orientation
• Awareness of and ideally experience in successfully communicating with Health Authorities

• High level of proficiency in both local and English (written and spoken).
• Very good verbal and written communication skills.
• Ability to interpret and relay technical information.
• Very good time management.
• Proficiency with computer and software applications (. Microsoft Office).
• Demonstrates keen analytical skills and attention to detail.

• Able to work in a fast-paced environment with competing priorities.
• ability to work independently as well as part of the team.
• Awareness of and ideally experience in successfully communicating with Health Authorities
• Familiarity with pharmaceutical organizational structures, systems, and culture

Company introduction

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.