Regulatory Affairs Specialist

1 week ago

Petaling Jaya, Malaysia Philips Full time

**Job Title**: Regulatory Affairs Specialist

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

**In this role, you have the opportunity to make life better**
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

**You are responsible for**
- Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
- Plan, generate, and coordinate regulatory submissions for product/solution licensing
- Maintain existing regulatory filings/ licenses, managing updates and related change control processes
- Assists with implementation of global regulatory and roadmaps through understanding the Competitive market landscape and product Marketing strategy.
- Develop regulatory strategy, and if needed connect to regulatory SME’s and make regulatory plan
- Proactive stakeholder management with businesses/manufacturer
- Develops and facilitates regulatory submissions, for new products/solution, existing products/solutions
- Other regulatory projects as applicable.

**To succeed in this role, you’ll need a customer-first attitude and the following**
- Bachelor degree in related majors
- 1-2 years of experience in RA related role
- Proactive, good at communication skills, being able to deal with complex situations, high responsibilities and good at compliance mindset
- Proficient in English language

**How we work at Philips**
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:

- We believe in the importance of impactful collaboration:_ There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
- We embrace flexibility:_ Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
- We want to be at our best:_ The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

**Why should you join Philips?**
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

  • Regulatory Affairs Specialist

    2 months ago

    Petaling Jaya, Malaysia Materialise Full time

    Regulatory Affairs Specialist **Petaling Jaya, Malaysia** **Regulatory Affairs** **Hybrid** **Full-time** - The Regulatory Affairs Specialist is responsible for a range of regulatory activities and will be involved in several regulatory operations projects. Acting as an expert, you contribute to shaping the regulatory landscape and concepts of...

  • Regulatory Affairs Specialist

    2 days ago

    Petaling Jaya, Malaysia Materialise Full time

    Regulatory Affairs Specialist **Petaling Jaya, Malaysia** **Regulatory Affairs** **Hybrid** **Full-time** - The Regulatory Affairs Specialist is responsible for a range of regulatory activities and will be involved in several regulatory operations projects. Acting as an expert, you contribute to shaping the regulatory landscape and concepts of...

  • Regulatory Affairs Specialist

    2 weeks ago

    Petaling Jaya, Malaysia Biocare Pharmaceutical (M) Sdn Bhd Full time

    **Tasks & responsibilities** - Oversee the Regulatory Affairs division, providing leadership and guidance to a team of regulatory professionals. - Collaborate with cross functional teams, including R&D, Quality Assurance, Clinical Development, and Manufacturing to ensure regulatory compliance throughout the product lifecycle - Act as the primary point of...

  • Regulatory Affairs Pharmaceutical

    2 weeks ago

    Petaling Jaya, Malaysia BioCare Pharmaceutical Sdn Bhd Full time

    Biocare Group is a leading pharmaceutical company committed to improving global health through the development and commercialization of innovative healthcare products. With a strong focus on research and development, Biocare Group aims to provide safe and effective treatments for patients worldwide. **Summary** We are seeking an experienced and highly...

  • Regulatory Affairs Specialist

    2 weeks ago

    Subang Jaya, Selangor, Malaysia Materialise Full time

    Regulatory Affairs SpecialistPetaling Jaya, MalaysiaRegulatory AffairsHybridFull-time The Regulatory Affairs Specialist is responsible for a range of regulatory activities and will be involved in several regulatory operations projects. Acting as an expert, you contribute to shaping the regulatory landscape and concepts of Materialise's worldwide presence....

  • Regulatory Affairs Specialist

    1 week ago

    Petaling Jaya, Malaysia Johnson & Johnson Full time

    **Position Summary** - The Regulatory Submissions Professional is a member of the Local Operating Company Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life cycle management submissions are under the scope of the Regulatory Management Centre (RMC), and this...

  • International Regulatory Affairs Manager

    6 days ago

    Petaling Jaya, Malaysia AstraZeneca Full time

    Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to accelerate Regulatory approvals for new medicines in International markets as efficiently and effectively as possible so that no...

  • Regulatory Affairs Specialist

    2 weeks ago

    Subang Jaya, Selangor, Malaysia Biocare Pharmaceutical (M) Sdn Bhd Full time

    Tasks & responsibilities Oversee the Regulatory Affairs division, providing leadership and guidance to a team of regulatory professionals. Collaborate with cross functional teams, including R&D, Quality Assurance, Clinical Development, and Manufacturing to ensure regulatory compliance throughout the product lifecycle Act as the primary point of contact for...

  • Regulatory Affairs Specialist

    1 month ago

    Petaling Jaya, Malaysia Johnson & Johnson Full time

    **Essential Job Duties and Responsibilities** The Regulatory Submissions Professional is a member of the Local Operating Company Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life cycle management submissions are under the scope of the Regulatory Management...

  • Regulatory Affairs

    2 weeks ago

    Subang Jaya, Selangor, Malaysia United Italian Trading (M) Sdn Bhd Full time

    Positions:a) Pharmacistb) Regulatory Affairs Managerc) Regulatory Affairs Assistant Managerd) Regulatory Affairs Senior Executivee) Regulatory Affairs Junior ExecutiveResponsibilities: Responsible for all regulatory affairs, regulatory compliance activities, and submission of pharmaceutical and medical device products of the Company. Liaise with regulatory...

  • Associate Specialist of Regulatory Affairs

    1 week ago

    Petaling Jaya, Malaysia MSD Full time

    Job DescriptionRegulatory Affairs Associate SpecialistOpportunity to be a part of a global Regulatory Affairs organization in Malaysia!Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR AsiaJoin the premier biopharmaceutical company that has been in the business for more than 25 years and in AP for over 60 years.Key...

  • Regulatory Affairs Executive

    5 days ago

    Petaling Jaya, Malaysia Elanco Full time

    Education : EQUIVALENTEXPERIENCE **At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to...

  • Manager Regulatory Affairs

    3 weeks ago

    Petaling Jaya, Malaysia DKSH Full time

    **Location**:Petaling Jaya, MY, MY**Job Function**:Client and Customer Services**Requisition Number**:149489**Description**: **Job Summary** - **Responsible for providing regulatory expertise to Business Unit Healthcare, DKSH Malaysia Sdn Bhd, and for ensuring the company’s Pharmaceutical and Medical Device operations are in compliance with the...

  • Regulatory Affairs

    2 weeks ago

    Subang Jaya, Selangor, Malaysia Special Enhancement Sdn Bhd Full time

    This job is for a Regulatory Affairs (RA) Executive who prepares regulatory documentation and liaises with authorities to obtain product approvals. You might like this job because it involves ensuring compliance and resolving regulatory issues while working with different teams.Kota DamansaraFull-TimeJob DescriptionPrepare and submit regulatory documentation...

  • Sr Regulatory Affairs Specialist, Dx Malaysia

    7 days ago

    Petaling Jaya, Malaysia Danaher Full time

    In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located....

  • International Regulatory Affairs Manager

    2 weeks ago

    Subang Jaya, Selangor, Malaysia AstraZeneca Full time

    Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to accelerate Regulatory approvals for new medicines in International markets as efficiently and effectively as possible so that no...

  • Regulatory Affairs Specialist

    2 weeks ago

    Subang Jaya, Selangor, Malaysia Johnson & Johnson Full time

    Position Summary The Regulatory Submissions Professional is a member of the Local Operating Company Regulatory Affairs team andis responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life cycle management submissions are under the scope of the Regulatory Management Centre(RMC), and this Submissions...

  • Executive Regulatory Affairs

    3 weeks ago

    Petaling Jaya, Malaysia DKSH Full time

    **Location**:Petaling Jaya, MY, MY**Job Function**:Client and Customer Services**Requisition Number**:155287**Description**: **Job Summary** - Assist Senior Pharmacist, Regulatory Affairs to cover regulatory affairs matters of DKSH Malaysia Sdn Bhd, Business Unit Healthcare **General Responsibilities** - Assist in timely product registration and variation...

  • Associate Specialist of Regulatory Affairs

    1 week ago

    Subang Jaya, Selangor, Malaysia MSD Full time

    Job DescriptionRegulatory Affairs Associate SpecialistOpportunity to be a part of a global Regulatory Affairs organization in MalaysiaBased in Malaysia, named one of the Best Companies to Work for in 2019 by HR AsiaJoin the premier biopharmaceutical company that has been in the business for more than 25 years and in AP for over 60 years.Key...

  • International Regulatory Affairs Director

    3 weeks ago

    Petaling Jaya, Malaysia AstraZeneca Full time

    **_Are you a strategically focussed Regulatory professional with international experience and would like to play an integral part in bringing life changing medicines to patients? If you are please read on._** At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Creating a more agile and...