Cv Raman Nagar Bengaluru Karnataka National centre for excellence Jobs – 87 Open Jobs Today

Associate II, Pharma Regulatory Services
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Associate II, Pharma Regulatory Services

CELEGENCE
Bengaluru, Karnataka

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Job details

Qualifications

English
Information security
Master's degree
Bachelor's degree
Pharmacy
Communication skills
Information management
Time management

Full job description

Global Opportunities to Join the Celegence Team At Celegence, you have the opportunity to shine and truly make a difference. We have a growing organization where your inputs will be valued. We have roles for all levels; both recent graduates and experienced professionals. We are currently looking for applicants with the following backgrounds. Celegence offers competitive compensation and benefits, growth opportunities, and a supportive work environment. Celegence is an Equal Employment Opportunity Employer All employment decisions at Celegence are made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Celegence is committed to providing a positive work environment as a part of the core Organizational value and is free from discrimination and harassment, and we will not tolerate any form of unlawful discrimination or harassment. Why work at Celegence? Be a part of a remarkable journey! Collaborative Team Here at Celegence, you get a great team that always stands by you. Supportive Manager A supportive Manager who makes sure you are absolutely comfortable with the work you’re doing. HR team An amazing HR team who is always working up different ways to keep the employees motivated (also by sending lovely goodies every now and then). Leadership Team Here you get the best leadership team that is equally concerned about employee’s career growth as they are about the development of this organization.

Associate II, Pharma Regulatory Services

Bangalore
Onsite / Hybrid
Reporting to Director, Pharma RA Services

Qualifications

Bachelor’s degree in pharmacy, Regulatory Affairs, or a relevant Life Sciences field.
Master’s degree preferred.
RAC certification is a plus.

Experience

Minimum 3–4 years of relevant Regulatory Affairs experience.
Familiarity with the Life Sciences industry, preferably within Regulatory Affairs.
Understanding of global regulations related to pharmaceuticals, medical devices, and biologics in the context of regulatory service offerings.
Experience in creating customer-facing materials.
Ability to work independently.
Fluency in English.

Technical Skills

Hands-on experience with regulatory processes and related IT systems.
Experience with document-level publishing and submission-level publishing.
Familiarity with Regulatory Information Management Systems (RIMS), Document/Content Management Systems, and eCTD submissions.

Soft Skills

Strong verbal and written communication skills.
Strategic thinking and problem-solving abilities.
Ability to effectively influence and collaborate with others.

Competencies

Strong written and verbal communication.
Customer-focused approach.
Drive to deliver high-quality work.
Strong time-management and prioritization skills.

Personal Traits

Positive attitude.
Initiative and commitment.
Detail-oriented.
Team player.
Focused and sincere.
Perseverance.

Roles & Responsibilities

Serve as a member of the Centre of Excellence team responsible for the lifecycle management of assigned products.

Document-Level Publishing
- Author and publish technical regulatory documents based on client product requirements.

Submission-Level Publishing
- Compile dossiers in the required format for submission to relevant regulatory agencies.

Use and update Regulatory Affairs systems, including Regulatory Information Management Systems (RIMS), Document/Content Management Systems, and eCTD submission systems.

Manage activities across the product lifecycle, including registrations, variations, renewals, and submissions.

Prioritize assigned activities and consistently produce high-quality deliverables.

Ensure targets and compliance reporting requirements are achieved in accordance with established timelines for key deliverables.

Adhere to applicable regulatory guidelines, departmental SOPs, and client SOPs when preparing and delivering work.

Complete training provided by clients as well as required self-training and maintain appropriate training certificates and records.

Assist and support internal audits performed by clients.

Support the implementation of Regulatory Affairs systems for client or partner projects.

Understand and comply with the company’s Information Security Management System (ISMS) policies and processes.

Apply Now

Refine Your Search

national centre for excellence jobs in cv raman nagar bengaluru karnataka

Associate II, Pharma Regulatory Services

Senior Analyst, Transformation Delivery

Manager -Supplier Quality

General Manager - Design & Engineering

Associate - IT Assurance

Power Platform Support Analyst (Hybrid)

Agile Test Automation Engineer, Quality Assurance

Lead I - SAP COUPA Functional Lead

Manager – HIS Implementation

Senior Security Analyst

Program Head - FemTech

Associate Principal Data Architect

Data Portfolio Planning Manager

Chapter Manager – UCS Automation Team

SAP Functional Lead

Cloud and Enterprise Infrastructure Manager

OOABAP / SAP ABAP

Assistant Professor- SOL - Law (Bangalore Campus)

Principal Firmware Architect

Area Controller

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Associate II, Pharma Regulatory Services

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