Regulatory Affairs Manager

10+ years of regulatory affairs experience in the pharmaceutical and medical devices industry **Prior experience preparing and reviewing submissions to BPOM** - Experience in Submission of New Drug Applications, Generic Drug Applications, Medical Devices Registration - Experience in Post Marketing Maintenance, Lifecycle Management of Marketed Drugs and...

Tugas dan Tanggungjawab Regulatory Affairs: 1. Pemahaman Peraturan dan Perundangan: Tugas utama dari Regulatory Affairs adalah memahami dan mengikuti peraturan dan perundangan yang berlaku di Indonesia. Ini melibatkan pemantauan dan pemahaman terhadap peraturan yang dikeluarkan oleh otoritas regulasi terkait. 2. Perizinan dan Registrasi: Regulatory Affairs...

Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Wellesta CPI. The successful candidate will be responsible for developing and implementing regulatory strategies for drug approvals and lifecycle management.Key ResponsibilitiesDevelop and implement regulatory strategies for drug approvals and lifecycle...

Compliance Management ProfessionalPT. Prima Bersama Berkat, a prominent player in the heavy machinery industry, is looking for a highly experienced compliance management professional to lead our regulatory affairs function.The ideal candidate will have a deep understanding of regulatory frameworks and a proven track record of driving business growth through...

LUXASIA is the leading beauty omnichannel distribution platform of Asia Pacific that has successfully enabled brand growth for more than 120 luxury beauty brands. Our integrated brand-building capabilities include luxury retail, online commerce, consumer marketing, and supply chain management. Since 1986, the company has partnered the world’s finest...

**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...

Manage licensing and permitting processes for company establishment and operations. - Ensure compliance with Indonesian regulations and laws, including environmental and trade regulations. - Conduct research and analysis on government policies, incentives, and regulations affecting the company. - Provide legal advice and support on manufacturing management,...

**Introduction** At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. Are you ready to lead in this new era of technology and solve some of the world's...

About the RoleThe Global Regulatory Compliance Manager will play a crucial role in ensuring that our company remains compliant with all relevant regulatory requirements. This includes developing and implementing regulatory strategies, preparing and submitting regulatory dossiers, and ensuring compliance with FDA, EMA, MHRA, and other regulatory...

As Senior Vice President of Regulatory Affairs, you will be responsible for ensuring that we stay ahead of changing regulatory requirements in the financial services industry. This includes developing and implementing effective strategies to ensure compliance with regulatory requirements.You will work closely with the Board of Directors, Commissioners,...

Our client is a B2B cosmetic company. As part of their business growth, they are currently looking for experienced Regulatory Affairs to increase their operations **Key Responsibilities**: - Reviewing cosmetics products regulations in Indonesia - Ensure all products have distribution permit - Monitoring all products sold have the right information on PDP -...

Cermati Fintech Group is expanding its Compliance Team and seeking a seasoned Regulatory Affairs Specialist to support our growth. As the main person in charge for all compliance activities and initiatives, you will be responsible for ensuring business continuity by adhering to applicable laws and regulations.You will work closely with our stakeholders to...

**What You’ll Do for Us** - Leverage your scientific and regulatory expertise to enable business growth (innovation, acquisitions) by collaborating on solutions to address regulatory and policy risks in order to grow and expand our current and new beverage categories, which will influence the new product pipeline, mergers & acquisition opportunities, and...

**High Flyer Internship** High Flyer Internship is a 6-months program designed for dynamic and ambitious students eager to gain real life working experience under industry experts. You will be given real responsibiliti es and become the pilot that navigates the project from its departure until it reaches its destination. **If you have interest to analyze...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The Regulatory Affairs and Quality Supervisor (Lead) is responsible for execution of PT Indonesia quality assurance, registration policies and standards, and ensures the regulatory compliance to local and international regulations. The role will call for a strong strategic...

About the Ideal CandidateWe are seeking a mid-senior level professional with a Bachelor's degree in Law (S.H.) and at least 3 years of experience in a reputable law firm or the automotive industry. The successful candidate should have in-depth knowledge of compliance and regulatory frameworks in Indonesia, especially in the automotive sector, as well as...

**Job Description**: - Give initiative, design, execute, and monitor legal compliance activities to comply with regulation. - Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to comply with OJK regulation - Manage an organizations policies and objectives involving local, state, and federal...

**Company Description** Louis Dreyfus Company is a leading merchant and processor of agricultural goods. Our activities span the entire value chain from farm to fork, across a broad range of business lines, we leverage our global reach and extensive asset network to serve our customers and consumers around the world. Structured as a matrix organization of...

Senior Public Affairs Manager **Category**:Corporate Affairs **Location**:Jakarta, DKI Jakarta, ID **About the department** Novo Nordisk Indonesia is dedicated to addressing public health challenges and enhancing the quality of life for patients. As part of our Market Access & Public Affairs team, you will report to the Market Access & Public Affairs...

Job Description: - Experienced in BPOM Registration and BPOM Import permit - Knowledgeable to do Import Realization and LS Realization - Provide responses to regulatory agencies regarding product information or issues. - Train staff in regulatory policies or procedures - Coordinate internal discoveries and depositions with team - Develop and maintain...