GRRS, Sr Associate

GRRS, Sr Associate

JOB SUMMARY

The Global Registrations & Renewal Support Sr Associate (GRRS, Sr Associate) will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations. Product License Maintenance comprises coordination of regulatory compliance starting at drug development stage and reaching through the lifespan of the Product. Once a New Drug Application is approved, a host of activities are required to set up and maintain the new drug label and essential product information (known as drug listing data) to Pfizer’s website and FDA, the National Library of Medicine (Daily Med) Website and the Drug Registration and Listing System team. Compliance activities continue with coordination of information in support of New Drug Application Annual Reports and NDA Periodic Reports. In addition, in support of EEA markets, team members will be accountable for partnering with appropriate vendors in submission of A57 records to the EMA . Team responsibilities also include managing the coordination of regulatory ancillary documents (including legalization) and drug samples to support registration and approval products in International markets.

 

Responsibilities:

• Supports delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.
• Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. Drug listing and Establishment registrations.
• Delivery of Product License Maintenance Portfolio in a timely and quality manner.
• Contributes to the completion of project tasks and/or milestones.
• Organizes own work to meet project task deadlines.
• Learns and applies basic team effectiveness skills (e.g., commitment, feedback, consensus management) within context of immediate Work Team.
• Has fundamental knowledge of the principles and concepts of the discipline.
• Applies technical skills to achieve assigned tasks.
• Contributes to the completion of routine Work Team related tasks.
• Uses established procedures and methodologies.
• Uses technical skills to achieve assigned regulatory operational responsibilities to support submissions to the Regulatory Authorities.
• Applies fundamental knowledge of the relevant regulatory industry and local business environment.
• Has fundamental knowledge of clinical, regulatory and/or other relative stakeholder groups.
• Makes decisions that require choosing between limited options to resolve problems basic in their complexity.
• Performs work in a structured environment under direction from supervisor.
• Decisions impact own work and have limited effect on projects.
• Decisions have limited effect on the delivery of scheduled work and may affect allocation of existing resources.
• Exercises judgment to complete assigned tasks and has significant reliance on supervisor.
• Works in a structured environment under direct supervision.
• Uses established procedures to perform assigned tasks.
• Asks for guidance from other colleagues.
• Work is regularly reviewed for soundness of technical judgment, completeness, and accuracy.
• Communicates straightforward information, asks questions and checks for understanding.
• Participates and contributes as a team member.
• Is responsible for certain team deliverables.
• Implementation of solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes.
• Participation on global/local teams to complete assignments and tasks within a specific task force/project. Contributes to the completion of moderately complex projects.
• Liaison with internal stakeholders for issues regarding standards and processes, and drives resolution of these.
• Utilization support of electronic technologies for submissions and tracking of documentation.
• Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team.
• Applies technical skills and Work Team knowledge to achieve assigned work on projects/assignments.
• May act as a technical resource within own Work Team.
• Utilizes regulatory expertise, experience and technical skills to deliver on moderately complex tasks to support submissions to the Regulatory Authorities.
• Has a strong understanding of the relevant regulatory industry and local business environment.
• Has strong understanding of clinical, regulatory and/or other relative stakeholder groups.
• Works under general supervision.
• Performs assignments using established procedures and general instruction on the process and desired outcome.
• Uses a variety of communication tools and techniques to explain difficult issues and works to establish consensus

 

Qualifications:

• Undergraduate degree plus relevant experience as below, or demonstrated fluency with regulatory submissions publishing and understanding of application of technologies.
• Demonstrated ability to function autonomously in a matrix environment.
• Regulatory Expertise: Demonstrated knowledge of Regulatory compliance requirements, processes and systems.
• Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
• Technology: Experience and competency with Regulatory software, XML, Document Management, regulatory milestone reporting tools

 

Core Competencies:

Functional/Technical Skills:

• Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Acts Decisively – makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision.
• Seizes Accountability –will stand up and be counted; doesn’t shirk personal responsibility; can be counted on when times are tough; willing to be the only champion for an idea or position; is comfortable working alone on a tough assignment.
• Change Agile – can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn’t upset when things are up in the air; doesn’t have to finish things before moving on; can comfortably handle risk and uncertainty.
• Peer Relationships- can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.
• Influencing – Uses a range of effective communication styles and creates and inclusive environment with internal/external stakeholders to deliver goals and promote quality; uses diplomacy and tact and can diffuse high-tension situations comfortably.

 

Skills:

• Demonstrated knowledge of CFR as it relates to specific post-market submissions.
• Demonstrated knowledge of/experience with Pfizer Commercial Portfolio
• Ability to communicate information and analyses to a variety of audiences both verbal and written format.
• Demonstration of processes, tools and techniques for planning and monitoring multiple projects to established deadlines.
• Demonstrated coordination of activities in a highly regulated environment.
• Proven aptitude in project management and logistics.
• Demonstration of experience working in a challenging customer service environment.
• Proven experience managing or delivering through others in a team environment.
• Demonstrated attention to detail.
• Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers.
• Formal training in technical tools.
• Knowledge of drug development process.

 

Worker Type:

Regular

 Work Location Assignment: Hybrid (some office presence is required)

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.  

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility  

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.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

Regulatory Affairs