Senior Manager, Regulatory Affairs

3-5 years

Not Disclosed

Princeton Junction

10 Nov. 28, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Position: Senior Manager, Regulatory Affairs
Company: Sun Pharmaceutical Industries Ltd.
Location: Not specified (Hybrid work arrangement)

Why Join Us?

At Sun Pharmaceuticals, we believe in investing in our employees and creating a fulfilling work environment. We offer a hybrid work arrangement and an attractive benefits package that includes:

Medical, Dental, and Vision Benefits
Health Savings Account (HSA), Flexible Spending Account (FSA)
Prescription Drug Coverage
Telehealth and Behavioral Health Services
Income Protection – Short Term and Long Term Disability
Retirement Benefits – 401k Company Match from Day One
Group Life Insurance
Wellness Programs
Corporate Discounts on Cellular Phones, Entertainment, and Consumer Goods

About Sun Pharmaceuticals

Sun Pharmaceuticals is the fourth-largest specialty generic pharmaceutical company in the world with global revenues exceeding $4.5 billion USD. We provide high-quality, affordable medicines trusted by healthcare professionals and patients in over 100 countries. Sunology, our company culture, embodies Humility, Integrity, Passion, and Innovation, and it guides our efforts to improve global health.

Our Code of Conduct governs our operations and ensures our commitment to ethical business practices and delivering accessible healthcare to communities globally.

Job Summary

The Senior Manager, Regulatory Affairs will play a key role in the publishing and coordination of Global Regulatory Affairs (RA) submission activities. This includes managing submission processes, tracking submission status, ensuring compliance with regulatory requirements, and maintaining documentation. The role requires multitasking across various projects, collaborating with different teams, and managing the full regulatory submission lifecycle.

Key Responsibilities

Regulatory Submission Management:
- Handle publishing and coordination tasks for Global RA submissions.
- Support Global RA submission processes, ensuring compliance with eCTD structure and global filing requirements.
- Collaborate with cross-functional teams on submission strategies and status reporting.
- Track submission activities, generate reports, and provide updates to senior management.
Document Review & Quality Control:
- Validate and QC regulatory documents before submission to Health Authorities.
- Archive and track global eCTD, paper submissions, and regulatory correspondences.
- Ensure compliance with publishing aspects and submission standards.
Regulatory Infrastructure & Best Practices:
- Support infrastructure improvements and system updates related to submission tools and processes.
- Participate in process enhancements and the development of new or revised procedures.
- Maintain and update Health Authority Commitment trackers, including post-approval commitments (e.g., Annual Reports, DSURs, PSURs, etc.).
Training & Meetings Coordination:
- Coordinate internal, cross-functional, or external meetings and training as necessary.
- Assist with publishing activities for various regulatory submissions (e.g., NDAs, INDs, MAAs, 510(k)s).

Qualifications

Education:
- Associate or Bachelor’s degree required.
Experience:
- 3-5 years of experience in regulatory affairs, specifically in publishing and eCTD submission processes.
Skills & Knowledge:
- Specialized knowledge in eCTD publishing and regulatory submission tools.
- Strong timeline management and communication skills.
- Ability to work in a cross-cultural and cross-functional environment.
Abilities:
- Flexibility with spoken and written communication skills.

Sun Pharma’s Vision

"Reaching People and Touching Lives Globally" – At Sun Pharma, we are committed to making good health accessible and affordable to local communities and society at large. Our Sunology values of Humility, Integrity, Passion, and Innovation reflect our dedication to improving lives globally.

Disclaimer:
This job description is intended to provide a general outline of the responsibilities and qualifications for the role. It may evolve based on business needs.

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Senior Manager, Regulatory Affairs

Job Description

Why Join Us?

About Sun Pharmaceuticals

Job Summary

Key Responsibilities

Qualifications

Sun Pharma’s Vision

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