Up Quality assurance pharma Jobs – 3 Open Jobs Today

Regulatory Affairs Manager
Shukra Pharmaceuticals Limited. —Noida, Uttar Pradesh
- Full-time
- Engineering
- Microsoft Office
- Master's degree
- Health insurance
- Paid time off
Quick apply
Business Development Executive For Pharma industry
Novasun Pharmaceutical Solutions Pvt. Ltd —Muzaffarnagar, Uttar Pradesh
- ₹11,529.63 - ₹40,927.77 a month
- Full-time
- Sales
- Master's degree
- Bachelor's degree
- Flexible schedule
- Paid sick time
Quick apply
Team Lead – IT QA & CSV
RxLogix —Noida, Uttar Pradesh
- Full-time
- Master's degree
- SQL
- Bachelor's degree

More jobs to discover

Find similar jobs that you might be interested in.

Business Development Executive For Pharma industry
Novasun Pharmaceutical Solutions Pvt. Ltd —Muzaffarnagar, Uttar Pradesh
*Education:* Bachelor’s degree in Pharmacy (B.Pharm), Life Sciences, or an MBA in Pharma/Healthcare Management. Client retention and satisfaction rates.
₹11,529.63 - ₹40,927.77 a month
Quick apply
Senior Analyst, Corporate Development - M&A
Doceree —Noida, Uttar Pradesh
With 3-6 years of experience, you will focus on high-impact research, analysis, and modelling to fuel inorganic growth in health-tech, ad-tech, and pharma…

I want to receive the latest job alerts for quality assurance pharma in up

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

quality assurance pharma jobs near up

Quality Assurance Manager jobs in Noida, Uttar Pradesh

Quality Assurance Manager jobs in Pirangut, Pune, Maharashtra

Quality Assurance Manager jobs in Vapi, Gujarat

Quality Assurance Manager jobs in Badlapur, Maharashtra

Quality Control Food jobs in Tamil Nadu

Food Quality Control jobs in Andhra Pradesh

Quality Assurance Manager jobs in Delhi, Delhi

Quality Engineer,cmm Zeiss jobs in Coimbatore, Tamil Nadu

Social Media Manager Freelance jobs in Mumbai, Maharashtra

Regulatory Affairs Manager jobs in Ankleshwar, Gujarat

Regulatory Affairs Manager jobs in Mumbai, Maharashtra

Real Estate Marketing Manager jobs in Mumbai, Maharashtra

Regulatory Affairs jobs in Navi Mumbai, Maharashtra

Regulatory Affairs Manager jobs in Ahmedabad, Gujarat

Restaurant Manager jobs in Tamil Nadu

Business Development Executive jobs in Kakkanad, Kochi, Kerala

Business Development Executive jobs in Jp Nagar, Bengaluru, Karnataka

Business Development Executive jobs in Noida, Uttar Pradesh

Back Office Executive jobs in Vasai, Maharashtra

Business Development Executive jobs in Zirakpur, Punjab

Regulatory Affairs Manager

Shukra Pharmaceuticals Limited.
Noida, Uttar Pradesh

Quick apply

Job details

Full-time

Benefits

Provident Fund
Leave encashment
Health insurance
Paid time off

Qualifications

Engineering
Microsoft Office
Master's degree
Analysis skills
Project management
Quality assurance
Bachelor's degree
Organisational skills
B.E.
Quality systems
Leadership
Communication skills
Information management

Full job description

Job Title: Regulatory Affairs Manager

Location: Sector 88 Noida, Delhi NCR

Reports To: Head of Quality & Regulatory Affairs

Position Summary:

The Regulatory Affairs Manager is responsible for developing and executing regulatory strategies to ensure compliance with applicable laws, regulations, and industry standards. This role manages regulatory submissions, coordinates interactions with regulatory authorities, monitors regulatory changes, and partners with cross-functional teams to support product development, registration, commercialization, and lifecycle management.

Key Responsibilities:

Regulatory Strategy & Compliance:

Develop and implement regulatory strategies to support product development, market entry, and lifecycle management.
Ensure compliance with applicable regional and international regulations, standards, and guidance documents.
Interpret regulatory requirements and provide strategic recommendations to internal stakeholders.
Monitor emerging regulatory trends and communicate potential business impacts.

Regulatory Submissions:

Prepare, review, and submit regulatory applications, registrations, renewals, variations, and amendments.
Coordinate the compilation of technical documentation and supporting materials.
Manage submission timelines and ensure accuracy, completeness, and compliance.
Respond to regulatory authority questions, deficiencies, and requests for additional information.

Cross-Functional Collaboration:

Partner with Research & Development, Quality Assurance, Manufacturing, Clinical, Marketing, and Legal teams to ensure regulatory requirements are integrated into business processes.
Provide regulatory guidance during product development and change control activities.
Support product launches and market expansion initiatives.

Regulatory Intelligence:

Track changes in regulations, guidance documents, and industry standards.
Assess the impact of regulatory changes on existing and future products.
Develop action plans to maintain ongoing compliance.

Agency Interactions:

Serve as the primary point of contact for regulatory authorities and notified bodies.
Coordinate inspections, audits, and regulatory meetings.
Maintain professional relationships with regulatory agencies and external stakeholders.

Documentation & Record Management:

Maintain accurate regulatory files, submission records, and product registrations.
Ensure documentation is audit-ready and compliant with company procedures.
Support internal and external audits as required.

Team Leadership (if applicable):

Manage and mentor regulatory affairs specialists and associates.
Establish team goals, performance metrics, and development plans.
Promote continuous improvement and regulatory excellence within the organization.

Qualifications:

Education:

Bachelor’s degree in Engineering (B.E or B.Tech), and advanced certificates in Regulatory Affairs,
Master’s degree (M.E or M.Tech) or professional certification in Regulatory Affairs preferred,
Hiring for MedTech division,
Pharma background candidates would not qualify.

Experience:

8-15+ years of experience in Regulatory Affairs within medical devices, consumer healthcare, or a related regulated industry.
Demonstrated experience preparing and managing regulatory submissions.
Experience interacting with regulatory authorities and supporting audits/inspections.

Knowledge & Skills:

Strong understanding of applicable regulatory frameworks and quality systems.
Excellent project management and organizational skills.
Strong analytical and problem-solving abilities.
Effective written and verbal communication skills.
Ability to manage multiple priorities and deadlines.
Proficiency in regulatory information management systems and Microsoft Office applications.

Preferred Competencies:

Strategic thinking and business acumen.
Attention to detail and accuracy.
Leadership and stakeholder management skills.
Ability to work independently and collaboratively across functions.
Strong negotiation and influencing capabilities.

Key Performance Indicators (KPIs):

Timely completion of regulatory submissions.
Regulatory approval success rate.
Compliance audit and inspection outcomes.
On-time product registration and renewal activities.
Effectiveness of regulatory risk mitigation initiatives.
Cross-functional stakeholder satisfaction.

Benefits:

Health insurance
Leave encashment
Paid time off
Provident Fund

Work Location: In person

Quick apply

Refine Your Search

quality assurance pharma jobs in up

Regulatory Affairs Manager

Business Development Executive For Pharma industry

Team Lead – IT QA & CSV

More jobs to discover

I want to receive the latest job alerts for quality assurance pharma in up

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected