Regulatory Affairs Associate

5 days ago

Sydney, Australia Pfizer Full time

Use Your Power for Purpose

We are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will play a pivotal role in broadening and hastening patient access to Pfizer's medicines and vaccines.

What You Will Achieve

In this role, you will:

- Provide strategic product direction and interact with regulatory agencies to expedite approval of pending registrations.
- Represent regulatory interests to marketing, research project teams, and government agencies throughout the product lifecycle.
- Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports.
- Provide input to stakeholders for product development in line with business objectives, ensuring strategies are reflected in country plans and aligned with regulatory activities and commercial goals.
- Support the development of Regulatory Affairs by maintaining internal databases, tracking systems, and document management, and offering regulatory inputs for promotional material approval.

Here Is What You Need (Minimum Requirements)
- High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
- Demonstrated experience in regulatory affairs or in a regulated industry
- In-depth knowledge of the current health regulatory framework for drug regulatory procedures
- Strong problem-solving skills, attention to detail, and a quality and compliance orientation
- Excellent verbal and written communication skills, and fluent in English
- Proficient in MS Office Suite

Bonus Points If You Have (Preferred Requirements)
- A Master's degree along with relevant pharmaceutical experience
- Familiarity with electronic submission processes and regulatory information management systems
- Ability to work effectively in a fast-paced, dynamic environment
- Strong interpersonal skills and the ability to work collaboratively with cross-functional teams
- Excellent organizational and time management skills
- Ability to adapt to changing priorities and manage multiple tasks simultaneously
- Strong analytical skills and the ability to interpret complex regulatory guidelines and requirements

Work Location Assignment: Hybrid

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:
- Paid parental leave- Access to Health & Wellness apps- Career Growth Experiences program- Recognition & rewards program- Paid volunteer days- Life Insurance Benefits- Pfizer Learning Academy access to top content providers- Access to flu vaccines & skin checks- Options to purchase additional leave- Salary packaging & novated lease options

Regulatory Affairs

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