Specialist - Regulatory Affairs

2-3 years

Not Disclosed

Bangalore

10 Dec. 31, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Work Your Magic with Us!

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

Job Title: Specialist - Regulatory Affairs
Location: Mumbai

Purpose of the Role:
The Regulatory Affairs Specialist provides overall support for India-specific and product-related activities. This includes preparing regulatory submissions, supporting registrations, maintaining licenses, and ensuring compliance with regulatory and business requirements.

Job Responsibilities:

Assist in maintaining registrations and licenses of products in RA systems and databases (e.g., SharePoint).
Perform labeling reviews and assist in project creation in the Artwork Management system (WebCenter).
Ensure timely submission of renewals, site registrations, and minor product submissions to relevant Health Authorities in APAC countries.
Facilitate communication across the Regulatory Affairs (RA) team, both top-down and bottom-up.
Update the Veeva Vault regarding lifecycle management (LCM) activities such as MA renewal and site registrations.
Request sample collection via the K2 system.
Generate regional reports and process vendor payments.
Conduct regulatory intelligence searches for relevant countries and update the Country Regulatory Tool system.
Participate in regional, global, or local hub initiatives to support the region and hub.
Assist in reviewing and revising hub processes to improve efficiency.
Support country regulatory and cross-functional activities as required.

Other Activities:

Strategy Alignment: Ensure alignment with country-specific submission strategies for Site Registration submissions.
Dossier Readiness: Perform labeling reviews and assist in project creation in the Artwork Management system.
Application Submission: Support the country in renewal and minor product submissions to relevant Health Authorities.
Product Maintenance: Assist in maintaining registrations and licenses of products in RA systems and databases.
Additional Support: Provide support in other country regulatory and cross-functional activities, including generating reports, requesting sample collections, and processing vendor payments.

Who You Are:

Education: Bachelor’s or Master’s in Pharmacy or D. Pharma.
Experience: Minimum of 2-3 years of experience in the Indian regulatory market.
Skills: Fluent in written and spoken English. Experience with CDSCO, Import, and State FDA regulations.

What We Offer:

We are a diverse team that values perspectives and experiences from all backgrounds. We believe that diversity drives innovation and excellence, strengthening our ability to lead in science and technology. We are committed to providing opportunities for all employees to develop and grow at their own pace. Join us to help build a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

US Equal Employment Opportunities:
The Company is an Equal Employment Opportunity employer. No employee or applicant will be discriminated against based on 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 law. This policy applies to all employment decisions.

North America Disclosure:
If you reside in California, Colorado, Hawaii, Maryland, New York, Washington, or Washington, DC, you are eligible to receive additional information about compensation and benefits upon request. Please contact 855-444-5678, 8:00 am – 5:30 pm ET, Monday through Friday for assistance.

Notice on Fraudulent Job Offers:
Be cautious of third parties claiming to represent our company offering unauthorized job opportunities. Please refer to our official website for more information if you suspect a fraudulent source.

What We Offer:
In addition to financial rewards, we offer a range of attractive benefits:

Saving & Financial: Our 401(k) plan includes company-matching contributions and additional discretionary contributions each year. We also provide tax-advantaged accounts for healthcare, commuting, and life insurance.
Health & Wellness: Comprehensive medical, dental, and vision coverage, including virtual care through Telehealth and free behavioral health counseling.
Voluntary Benefits: Additional protection from healthcare costs and discounts on auto, home, pet insurance, and low-interest personal loans.
Work/Life Support: Generous paid time off, back-up daycare services, education assistance, and more.

Our Recruiting Process:

You Apply: Submit your application for the role that matches your qualifications.
We Screen: We review your application and determine if you’re a good fit.
We Assess: You will be interviewed by phone, video, or face-to-face.
Mutual Agreement: If you’re the right match, we hope you’ll join us!
Work Your Magic: Our onboarding process ensures you a smooth start.

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Specialist - Regulatory Affairs

Job Description

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