API Regulatory Affairs

2 weeks ago

Bengaluru, India Biocon Ltd Full time

Role - API Regulatory Affairs - DMF Filing/ Compilation (Global market)Level - Assistant Manager/Deputy Manager /Associate Manager Level:-Required Education/Exp :-Experience Req.: 7 yrs. - 15 yrs.Qualification: - M.Sc. / M.PharmaResponsibilities1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.2. Compilation and submission of DMFs globally for small molecule APIs in eCTD format and in-line with ICH and region specific (EU, US, Canada, Japan, Australia, Brazil, China, South Korea etc.) regulatory guidelines.3. Should have good knowledge of all the regulatory guidelines and API Regulatory processes.4. Compilation of response to queries received from Regulatory Agencies & customers globally and submission of response within the stipulated timeline.5. Review and submission of new DMFs, deficiency responses, amendments, updations to various regulatory agencies.6. Evaluation of change controls and updating to agencies by considering change categories.7. Should have hands-on experience in eCTD softwareCandidates with relevant exp., kindly share CVs to apply on :- mention below details while sharing CV :-- Total Exp?- Current CTC?- Total number of DMF filings?- Handling which major markets globally ?- Notice Period?- Ready to work in Bangalore (onsite) ? (5 Days working)

  • API Regulatory Affairs

    3 weeks ago

    Bengaluru, India Biocon Ltd Full time

    Role - API Regulatory Affairs - DMF Filing/ Compilation (Global market)Level - Assistant Manager/Deputy Manager /Associate Manager Level:-Required Education/Exp :-Experience Req.: 7 yrs. - 15 yrs.Qualification: - M.Sc. / M.PharmaResponsibilities1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.2....

  • API Regulatory Affairs

    4 weeks ago

    Bengaluru, India Biocon Ltd Full time

    Role - API Regulatory Affairs - DMF Filing/ Compilation (Global market) Level - Assistant Manager/Deputy Manager /Associate Manager Level:- Required Education/Exp :- Experience Req.: 7 yrs. - 15 yrs. Qualification: - M.Sc. / M.Pharma Responsibilities 1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc. 2....

  • API Regulatory Affairs

    3 weeks ago

    Bengaluru, India Biocon Ltd Full time

    Role - API Regulatory Affairs - DMF Filing/ Compilation (Global market)Level - Assistant Manager/Deputy Manager /Associate Manager Level:-Required Education/Exp :-Experience Req.: 7 yrs. - 15 yrs.Qualification: - M.Sc. / M.PharmaResponsibilities1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.2....

  • Api regulatory affairs

    5 days ago

    Bengaluru, India Biocon Ltd Full time

    Role - API Regulatory Affairs - DMF Filing/ Compilation (Global market)Level - Assistant Manager/Deputy Manager /Associate Manager Level:-Required Education/Exp :-Experience Req.: 7 yrs. - 15 yrs.Qualification: - M. Sc. / M. PharmaResponsibilities1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.2....

  • Regulatory Affairs Manager

    2 weeks ago

    Bengaluru, Karnataka, India Kumar Organic Products Full time

    Job Title: Regulatory Affairs ManagerDepartment: Regulatory Affairs / Quality & ComplianceReporting to: Head Regulatory AffairsJob Purpose:To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing...

  • regulatory affairs

    3 weeks ago

    bengaluru, India Randstad Full time

     What do we offer you? Competitive salary and benefits packageRemote work opportunitiesProfessional development and growth opportunitiesCollaborative and supportive team environmentChance to make a significant impact on a global scaleWork-life balance Who are you?We are looking for a dedicated and experienced Regulatory Affairs Specialist to join our...

  • Regulatory Affairs Associate

    7 hours ago

    Bengaluru, India ANRGI TECH Pvt. Ltd. Full time

    Job Title: Regulatory Affairs Associate – Authoring.  Role detailed classification Regulatory Affairs Authoring Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring and/or other...

  • Regulatory Affairs Associate

    7 hours ago

    Bengaluru, India ANRGI TECH Pvt. Ltd. Full time

    Job Description Job Title: Regulatory Affairs Associate – Authoring.  Role detailed classification Regulatory Affairs Authoring Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring...

  • Business Development Executive

    2 days ago

    Bengaluru, Karnataka, India Silmed Scientific - Global Regulatory Affairs Partner Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Company DescriptionSilmed Scientific is a global leader in regulatory affairs, specializing in delivering comprehensive end-to-end regulatory solutions for pharmaceuticals, medical devices, and biosimilars. With expertise in regulatory strategy and successful drug development, the company supports approvals across global markets including Europe, the US,...

  • Regulatory Affairs Associate

    2 weeks ago

    Bengaluru, India Parexel Full time

    **_Regulatory Affairs Associate _**: **Experience: RIM**: **Relevant experience in Regulatory and should be willing to work in EU Shifts (12:00 - 9.00 PM)**: - **Experience of handling RIM tools - Veeva Vault specifically.**: - **Basic Regulatory knowledge on regulations and Health Authorities.**: - **Excellent communication skills.** **Knowledge and...