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3 - 5 years

3 - 4 Lacs

Chennai

Work from Office

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTDs and RA dossiers. Conduct document reviews to ensure compliance with drug regulatory affairs requirements. Provide expertise on dossier preparation, drug regulatory affairs, and related matters. Collaborate with cross-functional teams to achieve project goals. Ensure timely submission of regulatory documents to relevant authorities. Desired Candidate Profile Bachelor's degree in Pharmacy (B.Pharma) from a recognized institution. 3-5 years of experience in pharmaceutical industry with a focus on drug regulatory affairs. Strong understanding of CTD, Document Review, Dossier Preparation, and RA processes.

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1 - 2 years

1 - 5 Lacs

Ahmedabad

Work from Office

GCS Medical College Hospital & Research Centre is looking for Executive - Quality to join our dynamic team and embark on a rewarding career journey. Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the l...

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8 - 13 years

10 - 15 Lacs

Chennai

Work from Office

We are looking for a Regulatory Affairs Professional for a leading pharmaceutical company based at Chennai location. Regulatory Affairs, RA ANDA, Product Lifecycle, Preparation & Submission, US Market, Formulation, Solid Orals or Injectables. Interested Candidates share your updated resume with srinidhi@bvrpc.com

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3 - 6 years

3 - 6 Lacs

Ahmedabad

Work from Office

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

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5 - 10 years

5 - 13 Lacs

Ahmedabad

Work from Office

Role Description This is a full-time, on-site role located in Ahmedabad for a Regulatory Affairs professional. The role involves preparing and reviewing regulatory documentation, ensuring compliance with regulatory requirements, coordinating regulatory submissions, and staying updated with evolving regulatory affairs. The candidate will work closely with cross-functional teams to support product registrations and regulatory submissions, ensuring adherence to relevant guidelines and standards. Qualifications Experience in Regulatory Documentation, Regulatory Compliance, Regulatory Requirements Knowledge of Regulatory Affairs and Regulatory Submissions in Europe / ROW / Emerging Market Strong ...

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4 - 9 years

8 - 15 Lacs

Ludhiana

Work from Office

Job Summary: The candidate at NPPA is responsible for monitoring, analyzing, and regulating pharmaceutical pricing. Key Responsibilities: Regulatory Compliance: Review pricing submissions from pharmaceutical companies and enforce compliance with pricing policies. Reporting: Prepare and present reports on pricing data, trends, and regulatory compliance for internal stakeholders. Policy Support: Assist in the development and implementation of drug pricing policies and strategies. Qualifications: Education: Bachelors degree Experience: Experience in pharmaceutical pricing, regulatory compliance, or related fields.

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10.0 - 20.0 years

5 - 15 Lacs

noida

Work from Office

Job Context: To support MIBG I-131 clinical programs and other JDI innovative products in the pipeline, The Regulatory Specialist will be reporting to the director of Regulatory Affairs and support the development of regulatory strategies related to JDI clinical programs, marketing applications in US and Canada and post-marketing activities. Challenges: 3. SCOPE and SIZE OF THE ROLE (Please indicate key metrics defining the size and scope of the role) Revenue / Operating Budget As per JDI RA budget plans Geographical Responsibilities (Global / International / Country / Area with in Country Will work with the team in Canada and based out of India Area of Impact (Dept. Location / Function or B...

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5.0 - 10.0 years

9 - 13 Lacs

bengaluru

Work from Office

Boeing India Pvt Ltd is currently looking for Associate Airworthiness & Regulatory Engineer to join their team in Bangalore, India. The Airworthiness & Regulatory Engineer (Regulatory Compliance) is responsible for ensuring that all aerospace products and processes comply with applicable airworthiness standards, regulations, and certification requirements. This role involves close collaboration with design, manufacturing, quality, and certification teams to support regulatory compliance throughout the product lifecycle, from design and development through production and delivery. Position Responsibilities : Participates in identifying, analyzing, and assessing regulatory and contractual comp...

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4.0 - 8.0 years

6 - 10 Lacs

patan

Work from Office

Roles and Responsibility Develop and implement strategic plans to achieve business objectives. Lead and manage a team of professionals to ensure high performance and productivity. Analyze market trends and competitor activity to identify opportunities and threats. Build and maintain relationships with key stakeholders and clients. Identify and mitigate risks to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to drive business growth and improvement. Job Requirements Proven track record of success in a senior management role. Strong leadership and management skills with the ability to motivate and inspire teams. Excellent communication and interpersonal...

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5.0 - 10.0 years

4 - 8 Lacs

patan

Work from Office

Roles and Responsibility Develop and implement effective business strategies to achieve organizational goals. Lead and manage a team of professionals, providing guidance and support. Analyze market trends and competitor activity to identify opportunities and threats. Build and maintain relationships with key stakeholders and clients. Identify and mitigate risks to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to drive business growth. Job Requirements Proven experience in management and leadership, with a minimum of 5 years of experience. Strong knowledge of business operations and management principles. Excellent communication, interpersonal, and pr...

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5.0 - 10.0 years

4 - 8 Lacs

chennai

Work from Office

Roles and Responsibility Develop and implement effective business strategies to achieve organizational goals. Lead and manage a team of professionals, providing guidance and support. Analyze market trends and competitor activity to identify opportunities and threats. Build and maintain strong relationships with clients and stakeholders. Identify and mitigate risks to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to drive business growth. Job Requirements Proven experience in management and leadership, with a minimum of 5 years of experience. Strong knowledge of business operations, finance, and marketing principles. Excellent communication, interpers...

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5.0 - 10.0 years

3 - 6 Lacs

bawal

Work from Office

Roles and Responsibility Develop and implement effective business strategies to achieve organizational goals. Lead and manage a team of professionals, providing guidance and support. Analyze market trends and competitor activity to identify opportunities and threats. Build and maintain strong relationships with clients and stakeholders. Identify and mitigate risks to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to drive business growth. Job Requirements Proven experience in management and leadership, with a minimum of 5 years of experience. Strong knowledge of business operations, finance, and marketing principles. Excellent communication, interpers...

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5.0 - 10.0 years

2 - 6 Lacs

gurugram

Work from Office

Roles and Responsibility Develop and implement effective business strategies to achieve organizational goals. Lead and manage a team of professionals, providing guidance and support. Analyze market trends and competitor activity to identify opportunities and threats. Build and maintain strong relationships with clients and stakeholders. Identify and mitigate risks to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to drive business growth. Job Requirements Proven experience in management and leadership, with a minimum of 5 years of experience. Strong knowledge of business operations, finance, and marketing principles. Excellent communication, interpers...

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2.0 - 7.0 years

2 - 6 Lacs

gandhinagar, dehgam, ahmedabad

Work from Office

B.Pharm / M.Pharm with 2 to 6 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

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1.0 - 5.0 years

2 - 7 Lacs

ahmedabad

Work from Office

We are hiring an International Regulatory Affairs Executive/Manager with expertise in regulatory documentation, CTD dossiers & query handling. Immediate joiners preferred. Candidates with 1+ year experience may also apply. Join our growing team!

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2.0 - 7.0 years

2 - 7 Lacs

nalagarh, baddi, panchkula

Work from Office

We have urgent requirement for : Profile : Drug Regulatory Affairs Executive Experience : 2 years to 8 years Location : Nalagarh Skills Required : CTD , ACTD, Dossier Prepration, ACTD, Row Market, Ukraine, Malaysia, Thailand , Mexico etc Interested Candidate can send resume at hr2@theonpharma.com or contact @ 7717304694

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4.0 - 7.0 years

12 - 17 Lacs

gurugram

Work from Office

Looking for a place that values your unique talents? Discover Stryker's award-winning culture. We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards not to mention various social and recreational activities, all of which are location specific. Job description What you will do Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertain...

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1.0 - 6.0 years

2 - 3 Lacs

mumbai suburban

Work from Office

to work at the office level, dossiers for pharma, 1-3 years regulatory experience, work related to FDA , product registration abroad etc. Required Candidate profile Graduate with Experience in Regulatory Affairs staying in Western line and ready to travel Borivali location. Perks and benefits As per Company Policy, 6 Days a week working

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14.0 - 19.0 years

2 - 5 Lacs

kerala

Work from Office

We are looking for a highly skilled and experienced professional to join our team as an Entrepreneur In Residence in the Management Consulting industry. The ideal candidate will have 14 years of experience. Roles and Responsibility Develop and implement business strategies to drive growth and expansion. Collaborate with cross-functional teams to identify new business opportunities and improve existing processes. Conduct market research and analyze industry trends to inform business decisions. Build and maintain relationships with key stakeholders, including clients and partners. Identify and mitigate risks to ensure compliance with regulatory requirements. Monitor and report on key performan...

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1.0 - 3.0 years

2 - 6 Lacs

bengaluru

Work from Office

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by...

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4.0 - 7.0 years

5 - 9 Lacs

vadodara

Work from Office

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Executive / Sr. Executive based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 4 - 8 yrs. with dossier filling experience in Europe & South Africa Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skills. Job Description: Review of product initiation form /extension form Review of technology transfer documents Dossier compilation / periodic updates in dossier checklist CTD/NeeS/eCTD Submission & correspondence with agency / customer CoPP Dossier onl...

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2.0 - 6.0 years

11 - 15 Lacs

ranchi

Work from Office

To drive sales and ensure business targets are achieved o Aggressively drive the sales numbers and achieve the business targets for Retail loan products and through cross selling while continuing to enhance and upgrade the client relationships.o Retain and expand the company's base of customers for retail loan product so as to ensure repeat business or referralso Maximize sales through a network and relationships to ensure strong businesso Develop and maintain strong liaisons with the clients for repeat business or referrals.o Ensure the files are processed from login stage to disbursement and liaise with internal departments (Operations and Credit) for completion.o Optimize team productivit...

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2.0 - 4.0 years

2 - 4 Lacs

mumbai, mumbai suburban

Work from Office

Position: Regulatory Affairs Executive Location: Andheri (E) Role & responsibilities Ensure that the company's products comply with the regulations of the regions where they are distributed. Keep up to date with national and international legislation, guidelines and customer practices. Prepare dossiers, documents and samples as per requirement of markets for participation in tenders. Collect, collate and evaluate scientific data from a range of sources and prepare dossiers as per the market demand in CTD /ACTD formats. Monitor and set timelines for registrations variations and renewal approvals and submissions. Write clear, accessible product labels and patient information leaflets. Advise c...

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4.0 - 8.0 years

10 - 15 Lacs

noida, gurugram

Work from Office

We are looking for a skilled Program Leader to join our team in the BPO/Call Centre industry. The ideal candidate will have 4 to 8 years of experience and be based in R1 RCM Global Private Limited. Roles and Responsibility Lead compliance programs to ensure adherence to regulatory requirements. Develop and implement effective compliance strategies to mitigate risks. Collaborate with cross-functional teams to identify and resolve compliance issues. Conduct audits and reviews to ensure compliance with industry standards. Provide training and guidance on compliance policies and procedures. Monitor and report on compliance metrics to senior management. Job Requirements Strong knowledge of compli...

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3.0 - 8.0 years

3 - 7 Lacs

panchkula

Work from Office

Role & responsibilities We are seeking an experienced and detail-oriented Executive Officer Drug Regulatory Affairs with a strong background in injectable dosage forms to join our regulatory team. The ideal candidate will be responsible for regulatory submissions, dossier compilation, and lifecycle management of products specifically targeting the Rest of the World (ROW) markets, with a focus on Asia (e.g., ASEAN, Middle East, South Asia). Key Responsibilities: Prepare, compile, review, and submit high-quality regulatory dossiers (CTD/eCTD formats) for injectable formulations for registration in ROW/Asian countries. Ensure that all submissions comply with country-specific regulatory guidelin...

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