GRCY-0, Regional Regulatory Affairs Associate

Job Id

289475

Bonifacio Global City, Metro Manila, Philippines

Job Type

Full-time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role:

• Executes all regulatory submissions in the assigned APAC countries per regulatory and business requirements, for both product and clinical trial applications
• Supports regional/local and global strategies, plans, and communicates registration and plans and generates options to obtain product approvals and supports product changes.
• Ensures ready to submit dossier is available as per respective countries requirements through timely dossier compilation.
• Coordinates labeling compliance and support promotional material process.
• Ensures regulatory activities for the assigned Asian countries and portfolio are tracked irrelevant company systems according to compliant procedures.
• Participates in business meetings with cross-functional teams & external customers and provide active and ongoing guidance within submission projects.
• Assists Global Regulatory Affairs department in the update, enhancement & creation of internal procedures.
• Reviews and assesses health authority regulations and competitor intelligence across Asia.
• Able to travel as per business need.

As Regional Product Lead

a. Project Development

b. Strategy Alignment

c. Dossier Readiness

d. Application Submission

e. Applicatioon Approval

f. Product Maintenance

Country Point of Contact (PoC) / Sub PoC

a. Project Development

b. Strategy Alignment

c. Dossier Readiness

d. Application Submission

e. Application Approval

f. Product Maintenance

g. stakeholder Management

Who You Are:

• Degree or higher degree in Life Science, Pharmacy or related discipline
• Excellent verbal and written English Skills.
• Minimum of 3 years of regulatory experience in Pharmaceutical Product Registration and Clinical Trial application.
• Demonstrated in- depth experience with preparation of regulatory documentation to support product and trial applications, as well as agency interactions.

(

FDA)
- Thorough knowledge of NDA, CTA/ CTD requirements. – Clinical Trial application / Common Technical Documents, New Drug Application
- Working knowledge in global organization with strong collaboration and stakeholder management skills, including cross functional
- Experience with regulatory authorization in at least one of APAC country

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity

US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information here.

Applicant Profile

Along with our brand-new career site, we've also revamped our application process. If you've applied for a position before April 16th 2025, you can log into your old profile to see the status of past applications. For the application you've will completed, and any in the future, you can create a new profile to check in on your status.

WHAT WE OFFER

Money makes the world go round. But at our company there's more than just financial rewards. We offer a range of attractive benefits to help you work your magic.

Saving & Finacial

Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year.

We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future.

Health & Wellness

We offer comprehensive medical, dental, & vision coverage-including virtual care through Telehealth & free behavioral health counseling sessions through our Employee Assistance Program.

We also offer a wellness incentive program and personalized support to help you navigate and use your benefits.

Voluntary Benefits

Our voluntary benefits provide additional protection from the high costs of healthcare not covered by health insurance.

We also have discount programs that offer exclusive savings on everything from auto, home, and pet insurance to low-interest personal loans.

Work/Life Support

We have several programs to support your work/life balance, including generous paid time off, back-up day care services, education assistance, and more.

OUR RECRUITING PROCESS

Depending on the position (level, functional area, country) the process can vary slightly.

You apply

Complete your online application for your preferred role(s) that match your interests and qualification. If you cannot find a suitable role please join our Talent Zone and stay connected for your next career opportunity.

We screen

We review your application and if we determine that you are a good fit we will move you to the selection process.

We assess

You are interviewed by phone, via video and/or face to face.

Mutual agreement

Ideally you are the perfect match for us We hope you consider us as your new employer.

Work your magic

To guarantee you a smooth start our onboarding preparation begins.

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