Regulatory Affairs Manager

Job Description

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 strong 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 opportunities.

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 (On-site)