Regulatory Affairs

3 months ago

Jakarta, Indonesia BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**Role Summary**:

- Responsible and accountable for all aspects of Regulatory Affairs and Quality for Indonesia
- Manage regulatory activities relating to specific portfolio of products/projects to ensure full compliance of registered/marketed Baxter products.
- Work with team in the design and definition of the Regulatory strategy for the products.
- Represent Baxter in local government, industry associations, and working groups discussions to ensure positive outcomes for the company.

**Essential Duties & Responsibilities**:
The following responsibilities for RA related Tasks:

- Initiate and develop complex regulatory project plans.
- Monitor applicable regulatory requirements; Identify & prioritize key areas of regulatory risk.
- Create and maintain regulatory files in a format consistent with requirements for registration activities; or activities supporting commercial operations.
- Provide regulatory advice to commercial, functional, and project teams.
- Respond to complex questions from regulatory authorities within strict timelines.
- Compile and submit, in a timely manner, regulatory documents according to regulatory requirements.
- Maintain and update existing regulatory authorizations.
- Manage distributor RA to ensure on time submissions, strategy execution and compliance.
- Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations.
- Prepare SOPs to reflect specific local requirements.
- Lead or represent Regulatory Affairs in project teams.

The following responsibilities for QA related Tasks:

- Implement the quality systems per procedures with compliance.
- Manage quality related activities for warehousing and distribution.
- Manage all the customer reports on quality related issues in timely manners. Escalate information through corporate system and follow up for improvement in product and service; act with customer in mind.
- Responsible for implement and follow up Field Action (FA) such as customer notification letters, product hold, product correction, advisory notice, or product recall activities.
- Ensure quality systems training to all stake holders.

**Education & Experience**:

- Must be a Licensed Pharmacist.
- Minimum of 4 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization.
- Knowledge of local MoH regulations.
- Scientific knowledge.
- Project management skills.
- Manage multiple projects and deadlines.
- Ability to multitask and prioritize.
- Interpersonal and communication skills.
- Strong negotiation skills.
- Understand basis of Quality Management System and Good documentation practices.
- Technical system skills (e.g. word processing, spreadsheets, databases, online research).
- Ability to work effectively in multinational/multicultural environment.
- Ability to identify compliance risks and escalate when necessary.

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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