Regulatory Affairs Associate

3 days ago

Jakarta, Indonesia Pfizer Full time

**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**:You will represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

The Regulatory Affairs Associate is expected to support expediting product commercialization by ensuring that local registration requirements are fulfilled and registration approvals are obtained in the shortest possible time

**Role & Responsibilities :**:**Regulatory Support**:

- Support the Head of Regulatory Affairs (HRA) to develop registration strategies, prioritize assignments, implement regulatory plans, adhere to local regulatory guidelines and requirements and coordinate multiple projects and activities in accordance with company’s strategic objectives.
- Support expediting product commercialization by ensuring that country’s registration requirements are fulfilled and registration approvals are obtained as quickly as possible.
- Review, analyse, coordinate and provide feedback to HRA in matters relating to new product submissions and post approval maintenance of products as required.
- Review and approve packaging labels, promotional material and other documentation as required for regulatory compliance, when required (if applicable).
- Provide document review in order to ensure the regulatory quality and scientific integrity of documents submitted to regulatory authorities and publications e.g. MIMS update.
- Support activities related to product licence maintenance and resolution of relevant regulatory issues.
- Support resolution of production and manufacturing issues, such as submission/negotiation strategy, sourcing issues, packaging issues, and compliance matters.
- Maintains awareness of changes to laws, regulations and requirements and keeps the other department managers informed of these changes as soon as possible.
- Support the maintenance of the relevant record and Pfizer Systems while ensuring timely updates as governed by the SOP.
- Provides oversight and monthly report of activities associated with the approval of a product including such activities as development and coordination of responses to Regulatory Authority inquiries, monitoring and informing with respect to product filings, approvals and launches and track performance against agreed timelines and budget.

**Communication**:

- Ensure effective communication and collaboration with stakeholders and other function leads (e.g. GCMC, RegOps, PGS, Commercial, Medical etc.).
- Interact and participate in negotiation discussions on regulatory matters concerning Pfizer’s portfolio/interest and also involve in relationship building with Regulatory Authorities and Industry Associations, as appropriate.
- Support HRA to anticipate changes in country registration policies and guidelines and keeps relevant Pfizer groups informed of changes in the regulatory environment.
- Keep abreast of the external regulatory environment, including competitor intelligence, local product and international regulatory and commercial strategies.
- Monitor and consult HRA for dissemination of information on changes to regulations affecting registration, manufacture, distribution and sale of Pfizer products

**Management**:

- Develop systems and process improvements to continuously improve support for Pfizer in the market place.
- Participate in and promote team building and provide a stimulating environment which encourages team and individual growth.
- Effectively plan and monitor self-performance to meet set objectives.
- Responsible as Subject Matter Expert for ePALMS (artwork management system).

**Regulatory Compliance**:

- Be accountable for regulatory compliance (of records and systems) within the area of responsibili

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