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SynZeal Research Hiring for API ADL, Business Development & Regulatory Affairs in Ahmedabad
Position Overview & Specifications
| Parameter | Official Specifications |
|---|---|
| Hiring Organization | SynZeal Research |
| Designation / Role | API ADL, Business Development & Regulatory Affairs |
| Functional Department | Production & Manufacturing |
| Work Location | Ahmedabad |
| Experience Requirement | 1-4 Yrs |
| Target Qualifications | B.Pharm, M.Pharm, B.Sc, M.Sc Life Sciences, Relevant Graduates |
| Application Procedure | Direct Official Online Submission / HR Notification |
| Official HR Contact | Recruitment@Synzeal.com |
Key Roles & Detailed Responsibilities
- Execute core operational deliverables for API ADL, Business Development & Regulatory Affairs aligned with SynZeal Research’s SOPs and compliance frameworks.
- Perform scheduled assessments, data verification, laboratory tests, or regulatory reviews as assigned.
- Maintain audit-compliant documentation and coordinate closely with cross-functional project leads.
- Adhere strictly to global regulatory mandates (cGMP, GCP, ALCOA+ principles).
Eligibility Criteria & Candidate Profile
- Educational Qualification: B.Pharm, M.Pharm, B.Sc, M.Sc Life Sciences, Relevant Graduates from an accredited university.
- Experience Level: 1-4 Yrs in relevant healthcare, pharma, or clinical research environments.
- Strong domain competencies, documentation precision, and communication capabilities.
- Demonstrated adherence to quality assurance and standard operating protocols.
Core Technical Competencies & Instruments Matrix
Candidates possessing hands-on proficiency across the following analytical tools, software systems, and regulatory standards will receive priority evaluation:
eCTD Dossier Compilation (Module 1 through Module 5)USFDA (ANDA / NDA / IND) & Health Canada FilingsEuropean Regulatory Submissions (DCP / MRP / Centralized)eCTD Publishing Platforms (Lorenz docuBridge / Extedo)Post-Approval Changes (Variations / Supplements / CBE-30)Summary of Product Characteristics (SmPC) & Patient Information LeafletsRegulatory Agency Deficiency Response Drafting & Lifecycle ManagementDrug Master File (DMF – Open & Closed Parts) SubmissionsRest of the World (ROW / ASEAN / ACTD) Dossier CompilationsICH Quality, Safety, and Efficacy Technical Guidelines
Daily Operational Workflow & Core Shift Duties
Detailed technical breakdown of standard shift activities, laboratory/plant floor execution, and daily operational deliverables for API ADL, Business Development & Regulatory Affairs:
Duty 1eCTD Dossier Module Compilation
Authoring and assembling CTD Module 3 (Quality / CMC) and Module 1 administrative documents for global regulatory filings.
Duty 2Regulatory Change Impact Assessment
Reviewing proposed formulation, process, or manufacturing changes for regulatory reporting categories (CBE-0, CBE-30, PAS, Type IA/IB/II).
Duty 3Health Authority Query Response
Coordinating with R&D, QC, and QA to compile technical data, extended stability records, and scientific justifications for agency queries.
Duty 4Packaging Artwork & SmPC Review
Reviewing packaging cartons, blister foils, package leaflets (PIL), and Summary of Product Characteristics against approved national label texts.
Duty 5Lifecycle Management & Renewals
Tracking post-approval commitments, variation approvals, license renewals, and annual report filings across global regulatory agencies.
Regulatory & Quality Compliance Framework
Candidates must demonstrate operational awareness and rigorous adherence to the following regulatory chapters and international standards governing this role:
ICH M4 Common Technical Document (CTD)
Global Submission Architecture
Standardized organization of Module 1 (Administrative), Module 2 (Summaries), Module 3 (Quality), Module 4 (Nonclinical), and Module 5 (Clinical).
USFDA 21 CFR Part 314 & 312
Drug Marketing Applications
Statutory rules governing New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), supplements, and post-marketing reporting.
EU Directive 2001/83/EC & Variations
European Medicinal Products Law
Binding European Union code for marketing authorization applications, DCP/MRP procedures, and Type IA/IB/II variation management.
Electronic Submission Standards (eCTD v3.2.2)
Agency Submission Specifications
XML backbone architecture, study tagging files (STF), leaf elements, and hyperlinking validation criteria.
Tailored Resume Guidelines for API ADL, Business Development & Regulatory Affairs
- Highlight targeted skill keywords relevant to API ADL, Business Development & Regulatory Affairs prominently in your technical skills block.
- Ensure project details and laboratory/clinical instrumentation (e.g. HPLC, Argus, EDC, Veeva) are explicitly listed.
- Keep the resume layout clean, modern, and formatted for high-ranking automated ATS parsing.
Technical Interview Assessment & Guidance
Q: What core technical competencies make you suitable for API ADL, Business Development & Regulatory Affairs at SynZeal Research?
Authoritative Answer: Discuss your hands-on experience, academic foundation, understanding of standard workflows, and compliance awareness.
Authoritative Answer: Discuss your hands-on experience, academic foundation, understanding of standard workflows, and compliance awareness.
Q: How do you ensure data integrity and documentation precision in your daily workflow?
Authoritative Answer: Reference ALCOA+ principles, SOP adherence, real-time documentation practices, and prompt deviation reporting.
Authoritative Answer: Reference ALCOA+ principles, SOP adherence, real-time documentation practices, and prompt deviation reporting.
Q: Why do you want to join SynZeal Research in this role?
Authoritative Answer: Highlight SynZeal Research’s market reputation, quality culture, and your commitment to contributing to their operational goals.
Authoritative Answer: Highlight SynZeal Research’s market reputation, quality culture, and your commitment to contributing to their operational goals.
Mandatory Documents Checklist for Interview & Verification
Ensure you organize the following original credentials and self-attested photocopies for technical interviews and HR onboarding verification:
Curriculum Vitae (2 Hard Copies)
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Academic Certificates & Marksheets
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Government Photo Identification
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Past 3 Months Salary Slips & Bank Records
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Relieving & Appointment Letters
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Passport Photographs & Professional Registration
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
Frequently Asked Questions (FAQ)
Q: What is the official application deadline for API ADL, Business Development & Regulatory Affairs at SynZeal Research?
Answer: Applications are processed on a rolling basis. Candidates are encouraged to apply as early as possible while the opening is active.
Answer: Applications are processed on a rolling basis. Candidates are encouraged to apply as early as possible while the opening is active.
Q: Are freshers eligible for this specific role?
Answer: Freshers (0 years experience) are welcome if indicated in the experience tag; otherwise relevant domain background is required.
Answer: Freshers (0 years experience) are welcome if indicated in the experience tag; otherwise relevant domain background is required.
Q: What is the standard evaluation and selection process for this opening?
Answer: The hiring process generally includes resume screening by talent acquisition, a technical assessment interview, and credential verification.
Answer: The hiring process generally includes resume screening by talent acquisition, a technical assessment interview, and credential verification.
Related Career Pathways & Functional Specializations
Associated functional specializations and recruitment tracks for API ADL, Business Development & Regulatory Affairs at SynZeal Research:
SynZeal Research Recruitment 2026SynZeal Research Careers IndiaSynZeal Research API ADL, Business Development & Regulatory Affairs VacancyAPI ADL, Business Development & Regulatory Affairs Jobs in AhmedabadRegulatory Affairs Specialist JobseCTD Dossier Submission CTDUSFDA EMA Regulatory FilingsDossier Preparation Module 1 to 5Regulatory Operations ExecutiveB Pharmacy Jobs 2026M Pharmacy Pharmacology CareersMSc Chemistry Jobs Pharma IndustryBSc Life Sciences CareersPharma Jobs in AhmedabadPharma Speed Post Verified Careers100% Free Pharma Job Portal
Application Procedure
- Carefully review the functional eligibility criteria, academic qualifications, and key duties specified for API ADL, Business Development & Regulatory Affairs at SynZeal Research above.
- Calibrate your resume to highlight relevant instrumentation, software platforms, or cGMP/GCP regulatory compliance.
- Ensure your contact details, active mobile number, and email address are up to date in your CV.
- Click the official application button below to access the direct employer recruitment portal or HR email channel with zero intermediary charges.
Official Application Protocol & Email Etiquette
Adhere strictly to corporate submission etiquette to ensure your profile is prioritized by talent acquisition filters:
Recommended Email Subject Line:
Application for API ADL, Business Development & Regulatory Affairs – [Your Full Name] – [Years of Experience] – [Highest Qualification]
Standard Resume File Naming:
[FullName]_[Qualification]_[Role]_Resume.pdf
Professional 3-Line Cover Note Template:
“Dear Hiring Team, Please accept my application for the API ADL, Business Development & Regulatory Affairs position at SynZeal Research. I hold a [Your Qualification] with [Your Experience] of hands-on expertise in [Key Technical Skills / Instruments]. My updated resume is attached for your review, and I am available for immediate technical evaluation.”
Direct HR Application Email: Recruitment@Synzeal.com
Submit your updated resume with subject format: Application for API ADL, Business Development & Regulatory Affairs – [Your Full Name].
Submit Application via Official HR Email (Recruitment@Synzeal.com)
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