Regulatory Affairs US- Executive

3 weeks ago

Mumbai, Maharashtra, India Unichem Laboratories Limited Full time
Experience - 5- 11 Years

Qualification- B. Pharm / M. Pharm

RESPONSIBILITIES

- Author high- quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidances assuring technical congruency and regulatory compliance.

- Identify the required documentation for US regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.

- Review and Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues proactively.

- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.

- Co-ordination with stakeholders on a regular basis to extend all technical support required from regulatory perspective.

- Actively participate as a member by contributing to the regulatory strategy, identifying critical issues and lessons learned.

DESIRED SKILLS

- Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle.

- Good technical knowledge, review skills and understanding of regulatory submissions.

- Strong knowledge of CTD /eCTD requirements for submission of dossiers.

- Ability to try new approaches when faced with challenges.

- Should have good analytical and learning attitude.

  • 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

    4 weeks ago

    Mumbai, Maharashtra, India CliniLaunch Research Institute Full time

    Job DescriptionPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB 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 profile...

  • Regulatory Affairs

    3 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

    3 days ago

    Mumbai, Maharashtra, India CliniLaunch Research Institute Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB 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 profile will ensure...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mumbai, Maharashtra, India Chemical Manufacturing Full time

    Job Title: Senior Executive / Assistant Manager – Regulatory Affairs Location: Mumbai, India (On-site) Employment Type: Full-time | Permanent Experience Required: 3 to 8 years Industry: Chemicals | Pharmaceuticals | Food & Beverages Job Function: Legal | Quality Assurance | Regulatory Affairs Salary: up to 9 LPA About the Role: We are hiring for...

  • Regulatory Affairs Executive

    4 days ago

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

    Designation:Regulatory affairs -Executive/ Sr. ExecutiveJob Location:MumbaiJob 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...

  • Regulatory Affairs Specialist

    3 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

    3 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

    3 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 /...

  • Manager-Biologics Regulatory Affairs

    1 week ago

    Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    You will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables...