AHMEDABAD · FULLTIME
Sr. Regulatory Affairs Executive/Assistant Manager
BKM Health
Ahmedabad · onsite · Posted 1d ago
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Undisclosed7–11 yrsfulltimeAhmedabad
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Section · 01
About this role
Sr. Regulatory Affairs Executive/Assistant Manager
Education : Bachelor s / Master s degree in Pharmacy or a related field.
Experience Requirement : 7 11 years of relevant experience in Regulatory Affairs for regulated markets (US/EU), with expertise in oral solid dosage forms.
Location: Ahmedabad, Gujarat (On-site)
Job Type: Full-time
Key Responsibilities:
- Plan, review, and submit assigned ANDA and NDA projects within established timelines.
- Drive end-to-end regulatory strategies for product registration and approval across US, EU, UK, and Canada markets.
- Oversee the preparation, review, and filing of regulatory dossiers, including NDAs, ANDAs, NDSs, and MAAs, ensuring timely submissions.
- Lead cross-functional team discussions to align submission strategies, define priorities, and establish realistic timelines based on evolving regulatory requirements.
- Perform global regulatory due diligence and comprehensive gap assessments to identify potential risks and develop mitigation strategies for US, EU, UK, and Canada filings.
- Monitor evolving, region-specific regulations and provide strategic guidance to cross-functional teams to ensure compliance.
- Manage regulatory queries, deficiency responses, and communications with regulatory agencies.
- Provide regulatory strategic input on product development programs, labeling, risk management, and product lifecycle management.
- Maintain and update the global regulatory tracking database, ensuring the completeness and accuracy of regulatory records.
- Mentor and guide junior Regulatory Affairs team members to support professional development and team effectiveness.
- Support due diligence activities for in-licensing and business development opportunities.
Required Qualifications & Skills:
- Bachelor s or Master s degree in Pharmacy or a related field.
- 7 11 years of relevant Regulatory Affairs experience in regulated markets, particularly the US and EU.
- Demonstrated success in independently leading and managing multiple NDA and ANDA submissions through the full FDA review cycle.
- Strong knowledge of ICH guidelines, regulatory dossier preparation, eCTD submissions, and deficiency response management.
- Advanced proficiency in eCTD authoring and publishing platforms such as Lorenz docuBridge, Extedo, Veeva Vault RIM, or equivalent systems.
- Familiarity with the FDA Electronic Submissions Gateway (ESG) and Health Canada Common Electronic Submissions Gateway (CESG).
- Strong cross-functional leadership, strategic planning, problem-solving, and communication skills.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
Due DiligenceProduct Life Cycle ManagementDossierRegulatory AffairsEctdDossier PreparationAuthoringProduct RegistrationPharmacyBusiness DevelopmentOral Solid DosageCommunication SkillscomplianceNDAProduct Development