Regulatory Affairs

2 weeks ago


Andheri Mumbai Maharashtra, India The Hiring Experts Full time

**Job Title: Regulatory Affairs for a reputed pharmaceutical company**

1. Review all technical documents for submission of ANDA submission and post-approval submissions.

2. Ensuring all compiled ANDAs comply with current FDA guidelines and expectations to minimize deficiencies.

3. Preparation and review of pre-ANDA meeting packages, and controlled correspondences.

4. To track all changes from time to time in the product life cycle for ANDAs. Ensure all changes comply with current FDA thinking and expectations.

5. Preparation and review of supplements for changes in ANDA. Ensured to have post-approval compliance at risk-based assessment i.e. determining and evaluating appropriate filing categories e.g. CBE-0/CBE-30/PAS.

6. To track all changes from time to time in the annual report period of approved products and ensure submission of all changes to the FDA with detailed change history.

7. Evaluation of change control/deviation and review of technical documents in its support. Facilitating regulatory audits along with another department of the plant.

8. To maintain an internal regulatory database with all requisite details and necessary supporting documentation to facilitate the operation of the regulatory affairs department within the organization.

**Skills Required**:
1. Well verse with ICH, US FDA and relevant guidelines

2. Strategic thinking and proactive planning

3. Awareness of job responsibilities

4. Decision-making and problem-solving

5. Mentoring and interpersonal communication6. Ability to inspire teammates and recognition.

**Experience Required: 8-12 Years**

**Qualification: M. Pharma/ B.Pharma**

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹1,000,000.00 - ₹1,500,000.00 per year

Schedule:

- Day shift
- Monday to Friday

**Experience**:

- total work: 8 years (preferred)

**Speak with the employer**
+91 8692970927



  • Andheri East, Mumbai, Maharashtra, India Career Strategy Solutions Full time

    Seeking Drug Regulatory Affairs for a Company into Pharma Industry **Key Responsibilities**: - Research and stay updated on regulatory requirements and guidelines - Coordinate with cross-functional teams to gather necessary documentation and information for regulatory filings - Review and assess product labeling, packaging, and promotional materials to...


  • Mumbai, Maharashtra, India Glendale Biomed Pvt. Ltd Full time

    **Vacancy**: For Regulatory affairs officer **Job description** **Roles and Responsibilities** 2) To check artworks for regulated/ semi regulated countries. 3) To co-ordinate for documents and samples for regulatory submissions with manufacturing locations LL & TP 4) Handling of queries pertaining to regulatory submissions from various regulatory...


  • Powai, Mumbai, Maharashtra, India HaystackAnalytics Full time

    **Responsibilities** - Support in creating regulatory and quality policy plan as needed internally and externally - Work with internal personnel and external agencies to implement relevant regulatory requirements - Maintain and submit regular follow up documentation to regulatory/ quality agencies and participate in audits as needed - Document review and...


  • Mumbai, India AMPLE LEAP COGNITION & TECHNOLOGIES PVT LTD Full time

    **Job Description Form** **Fields** **Required Information** **Job Title** **Executive - Agriculture Regulatory Affairs** Reports To Manager Position Type New position Location Marol, Mumbai Job Overview Planning, undertaking, and overseeing regulatory work for local & export related products in Agri and Scientific support Responsibilities and...


  • Malad, Mumbai, Maharashtra, India SaffronBizz Solutions LLP Full time

    Greetings, We have an excellent opportunity for Regulatory Affairs officer. Location : Malad Experience :1 + year Role: We are seeking a skilled and licensed Regulatory officer to join our team. The products, managing purchase orders, and ensuring proper follow-up procedures. The officer will play a crucial role in maintaining compliance with...


  • Mumbai, India Amico Formulations LLP Full time

    **Post**: RA Executive **Experience**: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation) **Location**: Masjid Bunder, Mumbai - Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. - Preparation, Compilation & Review of Registration documents...


  • Mumbai, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team.Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) - WFOResponsibilities:1. Dossier collation and...


  • Worli, Mumbai, Maharashtra, India RecruitApt Full time

    Looking for RA Executive having min 2 years of Experience **Salary**: ₹40,000.00 - ₹50,000.00 per month Schedule: - Day shift **Experience**: - Regulatory Affairs: 2 years (required) Work Location: In person **Speak with the employer** +91 8002870884


  • Mumbai, Maharashtra, India Apotex Pharmachem India Pvt Ltd Full time

    Apply for Executive Regulatory Affairs, Regulatory Intelligence, Career Progress Consultants in Mumbai for 3 - 6 Year of Experience on


  • Mumbai, India Apotex Pharmachem India Pvt Ltd Full time

    Apply for Executive Regulatory Affairs, Regulatory Intelligence, Career Progress Consultants in Mumbai for 3 - 6 Year of Experience on TimesJobs.com.


  • Mumbai, India Zieva Farm Pvt Lt Full time

    Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies - Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications, Product packaging, Artwork etc. - Provide expert regulatory input...


  • Mumbai, India Double HR Consultancy Full time

    Mumbai, Vile Parle, Dombivli East Regulatory Affairs Executive Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience in the same industry. **Job Description**: - Managing regulatory...


  • Mumbai, India Vodafone Idea Full time

    Job Req ID: 18261- Location: Mumbai, IN- Function: Other- About: **Role** Circle Head - Regulatory Affairs & Nodal **Function / Department** Regulatory Affairs & Nodal **Location** Mumbai **Band** M3 **Job Purpose** Very high level of relationship management in the circles to mitigate any business risk. Act as Interface between Circle Cross...


  • Mumbai, India Colgate-Palmolive Full time

    Relocation Assistance Offered Within Country 156756 - Mumbai, Maharashtra, India **Who We Are** Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries...


  • mumbai, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team.Job Titles: Executive / Senior Executive / Assistant Manager - Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) - WFOResponsibilities:1. Dossier collation and...


  • Mumbai, India Pharma Jobs India Full time

    **EXECUTIVE DRUG REGULATORY AFFAIRS (PHARMA-FORMULATIONS)** Job Responsibility - Preparation and submission of dossiers as per countries assigned. - To handle inquiries from Regulatory Authorities related to company and product registration. - Submission of Registration Dossiers in EU, Semi-Regulatory and Emerging market. - FDA related work - Application...


  • Mumbai, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team.Job Titles: Executive / Senior Executive / Assistant Manager - Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) - WFOResponsibilities:1. Dossier collation and...


  • Mumbai, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team. Job Titles: Executive / Senior Executive / Assistant Manager - Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) - WFO Responsibilities: 1. Dossier collation...


  • Mumbai, India Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team.Job Titles: Executive / Senior Executive / Assistant Manager - Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) - WFOResponsibilities:1. Dossier collation and...


  • Mumbai, India Double HR Consultancy Full time

    Mumbai VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience...