Regulatory Specialist

Use Your Power for Purpose

At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the dynamic regulatory environment demands forward-thinking and meticulous attention to detail. Your work will ensure that our documentation processes are efficient and compliant, ultimately contributing to the timely delivery of life-saving medicines and vaccines to those in need.

What You Will Achieve

In this role, you will:

• Manage an efficient documentation system, ensuring compliance with regulatory requirements and maintaining record retention and information services.
• Interpret documentation standards, policies, and operating procedures, identifying submission components, and coordinating the assembly of regulatory dossiers.
• Maintain continuous contact with local, regional, and divisional customers, keeping up-to-date with product information and regulatory changes.
• Explain complex issues and establish consensus within the team through effective communication skills.
• Inform relevant internal stakeholders about the regulatory authority's approval of changes to the packaging component for assigned products to ensure their timely and accurate implementation.
• Provide guidance and supervise the operations team in preparing documents, particularly on technical aspects such as product specifications and certificates of analysis.
• Review all documents and dossiers related to submissions of new product registration, line extensions, post-approval changes, and license renewals, ensuring compliance with local regulatory requirements.
• Support the Regulatory Affairs Lead and Managers in the timely preparation of reports, perform data entry and quality control tasks, and keep the Safety team informed of adverse events according to relevant SOPs.

Here Is What You Need (Minimum Requirements)

• BA/BS with at least 2 years of experience or MBA/MS with any years of experience
• Demonstrated experience in Regulatory Affairs or a related function within the pharmaceutical sector
• Proven ability to oversee and provide Quality Control support
• Strong knowledge of National and Clinical Trials legislation and guidelines
• Ability to interpret and relay technical information accurately
• Proficiency in English, both verbal and written
• Proficiency in computer and software applications

Bonus Points If You Have (Preferred Requirements)

• A Master's degree with relevant pharmaceutical experience
• Experience in managing documentation systems within a regulatory environment
• Familiarity with global regulatory requirements and submission processes
• Strong analytical and problem-solving skills
• Excellent organizational and time management skills
• Ability to work independently as well as collaboratively within a team
• Adaptability and flexibility in a dynamic work environment
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

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 Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

Regulatory Affairs