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