Sr/Jr Regulatory Affairs- Healthcare/ Pharma- Borivali/ Boisar

19 hours ago

Borivli, Maharashtra, India Pink Sky HR Services Full time ₹ 40,000 - ₹ 10,00,000 per year

Sr/Jr Regulatory Affairs- Healthcare/ Pharma- Borivali/ Boisar

WFO- 6 days

Key Responsibilities:

  • Prepare, compile, and review dossiers and Drug Master Files (DMFs) for submission to regulatory agencies across developing nations.
  • Analyze and interpret guidelines from WHO, USFDA, EMA, and regional health authorities to ensure documentation meets regulatory standards.
  • Collaborate with cross-functional teams—R&D, manufacturing, quality assurance, and supply chain—to gather required data and documentation.
  • Ensure completeness, accuracy, and compliance of technical documents, including CTD structure.
  • Respond to regulatory queries and provide clarifications or supporting data as needed.
  • Adapt documents to meet region-specific requirements while maintaining confidentiality and data integrity.
  • Track and manage submission timelines and audit readiness.
  • Support inspections and audits by preparing documentation and addressing findings.

Qualifications:

  • Bachelor's/Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
  • 3–7 years of experience in pharmaceutical regulatory documentation.
  • Demonstrable experience in preparing dossiers and DMFs for global submissions.
  • Good understanding of ICH guidelines, WHO prequalification, GMP, and local compliance frameworks.
  • Experience working with emerging markets, especially in Africa, Latin America, or Southeast Asia is a plus.
  • Excellent written and verbal communication skills in English.
  • Strong organizational and multitasking abilities.
  • Ability to work independently and coordinate with multiple stakeholders.

Preferred Skills:

  • Familiarity with regulatory submission tools and templates.
  • Knowledge of pharmacovigilance and post-marketing requirements.
  • Exposure to different therapeutic segments such as APIs, formulations, or vaccines.
  • Language skills (Spanish, French, Portuguese) are desirable but not mandatory.

Please share your resume at

Job Type: Full-time

Pay: ₹400, ₹1,000,000.00 per year

Work Location: In person

  • Director Regulatory Affairs

    1 week ago

    Borivli, Maharashtra, India Michael Page Full time

    Be part of fastest growing medical AI company success storyBe the primary liaison for quality system management and regulatory affairsAbout Our ClientFast growing medical AI company developing cutting edge solutions that enhance patient outcomes.Job DescriptionManage regulatory submissions, lead a team, ensure product compliance, and strategically navigate...

  • Sales Engineer

    4 days ago

    Borivli, Maharashtra, India ACE Technologies Group Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Company DescriptionACE Technologies is one of India's leading companies that cater to the technological needs of industries encompassing Pharma & Healthcare, Food & Beverages. We provide innovative solutions to enhance operational efficiency and ensure regulatory compliance. Our team is dedicated to delivering cutting-edge technology and exceptional service...

  • Director of Global Regulatory Compliance

    1 week ago

    Borivli, Maharashtra, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 30,00,000

    Regulatory Affairs Expert OpportunityWe are seeking an experienced Regulatory Affairs Director to manage regulatory submissions, lead a team, ensure product compliance, and strategically navigate global market entry.The successful applicant will have deep knowledge of AI regulations, Software as a Medical Device (SaMD), global regulatory frameworks like FDA,...

  • Senior Graphic Designer

    2 weeks ago

    Borivli, Maharashtra, India Centrix Healthcare Full time US$ 90,000 - US$ 1,20,000 per year

    Job Title: Senior Graphic Designer, Pharma BackgroundLocation: MumbaiExperience Required: 4+ yearsIndustry: Pharmaceuticals / HealthcareQualification: BFA / MFA / Bachelors degree in Graphic Design, Visual Communication or related fieldJob Summary:We are seeking a highly skilled and creative Senior Graphic Designer with a strong background in the...

  • Medical Affairs Leader

    1 week ago

    Borivli, Maharashtra, India beBeemedicalaffairsleader Full time ₹ 1,04,000 - ₹ 1,30,878

    Job DescriptionWe are seeking an experienced Medical Affairs Leader to drive the strategic development and implementation of medical strategies, programs, and initiatives that support our business objectives. The successful candidate will be responsible for providing tactical and strategic inputs, as well as business/technical expertise, to Product...

  • Salesman Pharma

    2 weeks ago

    Borivli, Maharashtra, India Nakshatra Skill Development Campus PVT Full time ₹ 1,80,000 per year

    Post: Sales ExecutiveLocation: Borivali - GoraiQual: Any Graduate / undergraduateExp: Minimum 1+ year of experience in SalesSalary: 18KSkills: Field SalesJob Type: Full-timePay: ₹15, ₹18,000.00 per monthWork Location: In personSpeak with the employer

  • AGM/DGM Export Sales

    1 week ago

    Borivli, Maharashtra, India Symphoni Hr Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Role & responsibilitiesTo develop and expand the Africa marketfield force, distributors' stock, sales statement and secondary sales tracking country wise.Business Development & Promotional inputsDevelopment and finalization of distribution and agencies.Coordination with Commercial Dept. w.r.t shipments & orders, also with Regulatory Affairs and Technical...

  • Vice President

    2 weeks ago

    Borivli, Maharashtra, India Royal Pharma Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    We are looking for a passionate and strategicVice President – Marketing & BD (API & Advanced intermediates)with deep expertise in the pharmaceutical industry, particularly APIs & Advanced intermediates . The ideal candidate will be responsiblefor marketing and BD function of API ( Active Pharmaceutical Ingredients & Advanced intermediates ), lead product...

  • Project Consultant, Public Affairs

    1 week ago

    Borivli, Maharashtra, India APCO Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Job Brief We are looking for a proactive and detail-oriented Project Consultant to join our team. The ideal candidate is proactive, resourceful, and driven to perform at a high level. You'll be expected to think critically, take initiative, and deliver with precision as you help clients navigate uncertainty, manage complexity, and deliver impact across the...

  • Senior MIS

    2 weeks ago

    Borivli, Maharashtra, India Dermis Oracle Full time ₹ 4,32,000 - ₹ 7,20,000 per year

    Designation:Sr Executive / Asst Manager -MISDepartment:Commercial OperationReporting to:AGM - SFELocation:Mumbai, BorivaliCTC:4-6 LPAKey Responsibilities:1.Data Collection & Validation Data GatheringIncentives and CompensationSales Performance ReportingReporting & Analysis:KPI Monitoring (SFA)Root Cause AnalysisAd hoc AnalysisCross‐Functional...