Regulatory Affairs Manager :
We are seeking a highly experienced Regulatory Affairs Manager responsible for end-to-end regulatory submissions for US and Canadian markets with a robust focus on oral solid dosage forms.
The role requires expertise in ICH guidelines, dossier preparation (eCTD), deficiency response management, and cross-functional leadership to ensure timely approvals and compliance.

Job Responsibility:
Planning, reviewing and submission for assigned ANDA and NDA projects within timelines.
Drive end-to-end regulatory strategies for product registration and approval across US, EU, UK, and Canadian markets by managing the submissions.
Oversee the end-to-end preparation, review, and filing of regulatory dossiers (NDAs, ANDAs, NDSs, and MAAs to ensure 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 mitigation strategies for US, EU, UK, and Canada filings.
Monitor evolving,



region-specific regulations and proactively provide strategic guidance to cross-functional teams to ensure compliance.
Handle regulatory queries, deficiency responses, and agency communications.
Provide regulatory strategic input on product development programs, labelling, risk management, and life-cycle management.
Maintain and update the global regulatory tracking database; ensure completeness of regulatory records.
Mentor and guide junior regulatory affairs staff.
Support due diligence activities for in-licensing and business development prospects.

Required Qualification & Skills:
Bachelor's / Masters degree in Pharmacy or related field.
1015 years of relevant experience in Regulatory Affairs for regulated markets (US/EU)
Demonstrated success independently leading and managing multiple NDA, ANDA, and NDS NDA submissions through the full FDA review cycle.
Advanced proficiency with eCTD authoring/publishing platforms (Lorenz docuBridge, Extedo, Veeva Vault RIM, or equivalent).
Familiarity with FDA Electronic Submissions Gateway (ESG) and Health Canada CESG.

Experience: 10 to 12 years

Location: Ahmedabad, Gujarat (In office)

📌 Regulatory Affairs Manager Ahmedabad (India)
🏢 BKM Health
📍 India