Regulatory Affairs
19 hours ago
**Responsibilities**:
- **Regulatory Compliance**:
- Stay abreast of current and evolving regulations related to Drug License and FSSAI requirements.
- Ensure the organization's adherence to all applicable government regulations and standards.
- **Drug License Application**:
- Coordinate with regulatory authorities for timely approvals and compliance updates.
- **FSSAI License Application**:
- Collaborate with internal departments to gather necessary information for FSSAI compliance.
- Monitor and update FSSAI regulations to ensure ongoing compliance.
- **Government Liaison**:
- Act as the primary point of contact with government regulatory agencies.
- Build and maintain strong relationships with regulatory authorities to facilitate smooth communication and approvals.
- **Documentation and Record Keeping**:
- Establish and maintain a comprehensive system for documenting regulatory compliance activities.
- Ensure all relevant records, reports, and files are accurate, up-to-date, and easily accessible.
- **Quality Assurance**:
- Collaborate with the quality assurance team to develop and implement quality control measures in line with regulatory requirements.
- Conduct internal audits to identify and rectify potential compliance issues.
- **Training and Awareness**:
- Provide training to relevant staff members on regulatory compliance and changes in regulations.
- Foster a culture of awareness and accountability regarding regulatory requirements.
**Qualifications and Experience**:
- Bachelor's degree in Pharmacy, Life Sciences, or a related field.
- Proven experience as a Quality Assurance Executive with a focus on regulatory compliance, especially in Drug License and FSSAI.
- In-depth knowledge of Indian regulatory requirements and procedures.
- Strong understanding of quality management systems.
- Excellent communication and interpersonal skills.
- Ability to work collaboratively with cross-functional teams.
- Detail-oriented with a commitment to accuracy and compliance.
Pay: ₹300,000.00 - ₹400,000.00 per year
Schedule:
- Morning shift
Work Location: In person
-
Associate - Regulatory Affairs
19 hours ago
Gurugram, Haryana, India DDReg Pharma Full time-Full Time Gurgaon Posted 5 days ago Job title Associate - Regulatory Affairs - Reports to Senior Associate/Astt Manager/Manager - Regulatory Affairs - **Job purpose**: To carry out Regulatory Review and Compilation of Technical documentation & dossiers for - Various Markets in compliance to applicable regulations and guidelines. - **Duties and...
-
Regulatory Affairs
1 week ago
Gurugram, Haryana, India Pratham Search Full timeCurrently we require Regulatory Manager for Medical device. Location - Sohna, Haryana Minimum Experience - 4+ years in Medical devices Job profile: Key responsibilities: Spearheaded regulatory submission strategy for CE marking under EU MDR for Class IIa, IIb & III devices. Authored and maintained FDA 510 (K) submission, including predicate device...
-
Dra Executive
1 week ago
Gurugram, Haryana, India YRHRS Full time**Senior DRA Executive (Regulatory Affairs)** Ø Preparation and reviewing of administrative documents. Ø Preparation and Review of Dossier in CTD,ACTD and ECTD Format. Ø Preparing the SPC and SMPC as per country guidelines. Ø Preparation of Dossier for CIS, Africa countries, Gulf Countries, and south India countries. Ø Review and Making of...
-
▷ [Urgent] Regulatory Affairs Specialist
3 weeks ago
Gurugram, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Specialist Job Description Job title: Regulatory Affairs Specialist Your role: Regulatory Affairs Specialist - ISC will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs Team and help business with product registration in the India Sub Continent, actively providing value-added...
-
Dgm/sm - Regulatory Affairs - Cmc - Branded
1 week ago
Gurugram, Haryana, India Sun Pharmaceutical Industries Ltd Full time**Title**:DGM/SM - Regulatory Affairs - CMC - Branded**: - Date: Sep 24, 2025 - Location: Gurgaon - R&D - Company: Sun Pharmaceutical Industries Ltd **Job Title**: Sr. Manager / DGM**Business Unit**: Sun Global Operations**Job Grade** G9A/G8**Location**: GurgaonAt Sun Pharma, we commit to helping you **“Create your own sunshine”**— by fostering an...
-
Country Regulatory Affairs Manager
1 week ago
Gurugram, India Glanbia Full timeWe are seeking a highly experienced and detail-oriented Regulatory Affairs professional to manage regulatory compliance for our Sports Nutrition portfolio across India and international markets. This individual contributor role involves reviewing product formulations, labels, and claims, ensuring alignment with FSSAI and global regulatory frameworks, and...
-
Assistant Manager- Regulatory Affairs
5 days ago
Gurgaon, Haryana, India Johnson & Johnson Full timeAt Johnson Johnson we believe health is everything Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full...
-
Associate- Drug Regulatory Affairs us
4 days ago
Gurugram, Haryana, India DDReg Pharma Full timeDDReg Pharma DDReg Pharma Full Time Gurgaon Posted 4 hours ago **Job Purpose**: **Key Responsibilities**:Regulatory Compliance**: Strong understanding of U.S. regulatory requirements, particularly FDA guidelines, and will be responsible for preparing and submitting regulatory documentation for ANDA, maintaining compliance records, and liaising with...
-
Gurgaon, Haryana, India Maersk Full timeAt Maersk we believe in an integrated world Connected all the way We provide our customers with a simple end-to-end offering of products and services through a superior delivery network at sea on land and in the air taking the complexity out of supply chains and thereby improve the flow of foods goods data and materials to sustain people businesses and...
-
Deputy Manager Regulatory Affairs
1 week ago
Gurgaon, Haryana, India Haleon Full timeHello We re Haleon A new world-leading consumer health company Shaped by all who join us Together we re improving everyday health for billions of people By growing and innovating our global portfolio of category-leading brands - including Sensodyne Panadol Advil Voltaren Theraflu Otrivin and Centrum - through a unique combination of deep human understanding...