Regulatory Affairs

2 days ago

Gurugram Haryana, India Ethics Group Of Companies Full time

**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

    2 days 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

    2 weeks ago

    Gurugram, Haryana, India Pratham Search Full time

    Currently 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

    2 weeks 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...

  • Assistant Manager- Regulatory affairs

    2 weeks ago

    Gurugram, India myGwork - LGBTQ+ Business Community Full time

    Job Description This job is with Johnson & Johnson, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are...

  • Dgm/sm - Regulatory Affairs - Cmc - Branded

    2 weeks 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...

  • ▷ Immediate Start! Manager

    3 weeks ago

    Gurgaon, Haryana, India Sun Pharmaceutical Industries Full time

    JOB DESCRIPTION Position Manager Senior Manager Job Location Gurgaon Education M Pharm Department Global Regulatory Affairs Job Responsibilities Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU Canada...

  • Associate- Drug Regulatory Affairs us

    5 days ago

    Gurugram, Haryana, India DDReg Pharma Full time

    DDReg 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...

  • Medtronic - Director - Quality Assurance & Regulatory Affairs

    2 weeks ago

    Gurugram, India Medtronic (Medtronic)(279) Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life.Role Summary. The QARA Director for India will be responsible for leading a team supporting Quality...

  • Executive, Regulatory Affairs

    1 week ago

    Gurugram, Haryana, India Reckitt Full time

    Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...

  • Head Of Regulatory, Quality And Government Affairs South-asia

    2 weeks ago

    Gurgaon, Haryana, India Fresenius Medical Care Full time

    Responsible for Medical Device and Drug registration in CDSCO State FDA office and other government office Lead negotiations with key health authority agencies during development registration and product lifecycle activities to resolve regulatory issues and or negotiate approvals establish and maintain proactive and professional communication relationship...