Regulatory Affairs Specialist Jobs

The Position

Summary:

Regulatory Affairs Specialist will report into the Head of Regulatory, Quality Assurance, Government Affairs and Market access (Head of RAQA-GAMA), working in close collaboration with other functions and business teams to support the registration submissions, which align with company’s goal and objective.

Regulatory Affairs Specialist is responsible for coordinating a product registration requirements with relevant parties, compiling necessary documents for successful regulatory filings and have appropriate communication with MoH as part follow up activities for new products/indications/ variations and renewal submission.

In addition to her/ his main role as Regulatory specialist, this person also needs to support other regulatory and compliance projects according to direction from Head of Regulatory, Quality, Market Access & SHE (Head of RQMAS) which need to be aligned with prioritization in internal department and the organization e.g Market Access and public policy work.

Role and Responsibilities:

• Establish communication with Marketing/ SC/ Sales colleagues to share information about new products, line extensions and changes to currently approved products and review timelines for product approvals
• Request the documentation required for registration submissions for new registration, line extension, change to registered products/variants and product renewal
• Providing necessary support when there is a need from RAQA-GAMA department according to company directions
• Support in Market Access and public policy tasks, and not limited to monitor Regulatory environment monitoring and conduct analysis to provide some recommendation of strategic action for the company
• Preparation of submissions to the local health authority for new products, variations and renewal to existing products in line with Marketing launch plans, with guidance from senior regulatory colleagues as necessary
• Build constructive relationships with the local health authority by compiling and submitting high quality submissions and providing prompt responses to questions
• The Regulatory Affairs Specialist will be a member of the Regulatory, Quality, Government Affairs and Market Access Department, with responsibility for regulatory aspects of the assigned product portfolio/s and or projects (e.g IVDR)
• Liaise and establish cooperative relationships with relevant regulatory colleagues to ensure understanding of regulatory requirements in Indonesia and

Qualification and Knowledge:

• Bachelor of Pharmacy or Science with Pharmacist certification.(S.Si. Apt or S.Fam, Apt) is strongly preferred
• Good English proficiency (writing and speaking) is a must
• Excellent Interpersonal skills with the ability to build working relations both internally and externally
• Drive for results, Sense of urgency, self-motivated to deliver high quality work on time, good teamwork
• At least 2-3 year(s) of working experiences as Regulatory affairs in healthcare business (preference on Medical device or diagnostic industry)
• Has ability on analytical thinking and good in details, Creativity - Openness to new ideas, resourceful, well organized, cross-cultural competence and presentation skills

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.