Regulatory Affairs Executive

2 days ago

Mumbai, Maharashtra, India Talent Sutra Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Designation:
Regulatory affairs -Executive/ Sr. Executive

Job Location:
Mumbai

Job Summary:

The primary responsibility for the position is to oversee the daily activities of the Regulatory Affairs. Ensure that deliverables are being met based on planned submission timelines. Directs the development of submission of Product registration Dossiers, amendments, PSUR and Annual reports etc to Regulatory authorities. Queries response compilation and submission to Regulatory bodies.

Responsibilities:

Manages all the functions of the Regulatory Department including but not limited to-*Scheduling all the activities of the department.

Job Description:

  • Dossiers compilation /Review for ROW, ZAZIBONA, Emerging market and EU (National, DCP, MRP MA) applications.
  • Responsible for the Lifecycle management of assigned Products according to EU regulations and other country regulation where the Product is registered.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new product Dossiers and CMC variations.
  • CTD, ACTD Dossier compilation according to country requirements and understanding of E2E product development and filing strategies.
  • Maintaining database of Regulatory submissions.
  • Coordination and follow up with QC, QA, F&D, ADL, Manufacturing, packing teams, finished product manufacturers, contract manufacturer for getting all necessary technical documents as per CTD requirement.
  • Prepare and review SmPC, PIL, Artwork etc.
  • Ensure adherence to deadlines and Regulatory compliance of submission to health authorities.

  • Preparation of Application to Regulatory bodies for all necessary approvals, FDA, CDSCO and international Regulatory bodies.

  • Queries response compilation and submission to Regulatory Authorities for Product registration and renewal.

  • Post approval (PAS) compliance by compilation and review of documents.
  • Coordinating the inspection of the organization facilities, contract facilities and developing procedure to ensure Regulatory compliance.
  • Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals).
  • Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines.
  • Communicate design changes to existing products and company practices where necessary.
  • Plan and develop product trials and interpret trial data.
  • Stay up to date with the latest rules and regulations.
  • Any other task assigned by Head of department.

Education, Specialized skills and Knowledge:

  • Master degree in Pharmacy in any specialization.
  • Candidates must have 5+ Years of RA experience.
  • Knowledge of ROW, Emerging market, ZAZIBONA and EU market requirements and ICH guidelines is must. Minimum 4 years experience in EU submission is required.
  • Fluent spoken and written English.
  • Task oriented with learning attitude and team work skills.

  • Regulatory Affairs

    2 days ago

    Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...

  • Regulatory Affairs Executive

    2 days ago

    Mumbai, Maharashtra, India Illusion Dental Laboratory Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Title: Regulatory AffairsNo of Vacancy: 1Job Location: Andheri WestYears of Experience: 1-4 yearsWorking Days: Monday to SaturdayJob Summary:We are seeking a motivated and detail-orientedRegulatory Affairs Executiveto join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with...

  • Regulatory Affairs Specialist

    2 days ago

    Mumbai, Maharashtra, India Chemical Manufacturing Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Job Title:Senior Executive / Assistant Manager – Regulatory AffairsLocation:Mumbai, India (On-site)Employment Type:Full-time | PermanentExperience Required:3 to 8 yearsIndustry:Chemicals | Pharmaceuticals | Food & BeveragesJob Function:Legal | Quality Assurance | Regulatory AffairsSalary: up to 9 LPAAbout the Role:We are hiring for aSenior Executive /...

  • Regulatory Affairs Specialist

    2 days ago

    Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Position:Sr. Executive / Asst. Manager / Deputy Manager – Regulatory Affairs (Domestic)Location:Andheri, MumbaiQualification:M. Pharm. (Experienced preferred)Job Description – Regulatory Affairs (Domestic)The role requires strong expertise in theDrugs & Cosmetics Act and Rules,FSSAI regulations, andFDA-related activities. The profile will ensuretimely...

  • Senior Executive Regulatory Affairs

    2 days ago

    Mumbai, Maharashtra, India Orion Corporation Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    About your roleWe have vacancy for Global Regulatory Expert role in Regulatory Affairs team. We are looking for Executive/Sr. Executive. This individual will be based in Mumbai/ Hyderabad. The candidate has the possibility to utilize his/her own strengths with the support of the professionals.Your key responsibilitiesResponsible for preparation / checking /...

  • Office Regulatory Affairs

    2 days ago

    Mumbai, Maharashtra, India Kremoint Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Title / Designation Office Regulatory AffairsOrganization Name Kremoint Pharma Pvt. Ltd.Job Location VikhroliJob Description / ResponsibilitiesPrepare and compile dossiers for CTD, ACTD, and country-specific requirements for in-house, loan license, and third-party products for the ROW market.Apply for Free Sale Certificate (FSC) and Product Permission...

  • Regulatory Affairs Specialist

    2 days ago

    Mumbai, Maharashtra, India Tek Support Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Job Title:Regulatory Affairs Specialist Med/Pharma (Female)Location:RemotePosition Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring...

  • Regulatory Affairs Executive

    2 days ago

    Mumbai, Maharashtra, India IMPACT LABS Private Limited Full time ₹ 1,80,000 - ₹ 3,60,000 per year

    Licensing & Approvals:Obtain product permissions from relevant regulatory authorities.Prepare and submit applications for new manufacturing licenses.Liaise with government agencies to ensure timely approvals and renewalsDossier Compilation:Compile, review, and submit regulatory dossiers in CTD (Common Technical Document) and ACTD (ASEAN Common Technical...

  • Associate, Regulatory Affairs

    2 days ago

    Mumbai, Maharashtra, India Colgate-Palmolive Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Relocation Assistance Offered Within CountryJob Number # Mumbai, Maharashtra, India Who We Are Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world,...

  • Associate, Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Colgate-Palmolive Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Relocation Assistance Offered Within Country Mumbai, Maharashtra, IndiaWho We AreColgate-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 and territories...