Regulatory Affairs Executive : We are seeking a highly experienced Regulatory Affairs Manager responsible for end-to-end

regulatory submissions for the US and Canada 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, Canada 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, labeling, risk

management, and life-cycle management.

- Maintain and update the global regulatory tracking database; ensure completeness of

regulatory records.

- Mentor and provide guidance to junior regulatory affairs staff.
- Support due diligence activities for in-licensing and business development

opportunities.

Required Qualification & Skills :

- Bachelor's / Master’s degree in Pharmacy or related field.
- 10-15 years of relevant experience in Regulatory Affairs for regulated markets (US/EU)
- Demonstrated success independently leading and managing multiple NDA, ANDA, 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)

Pay: From ₹1,000,000.00 per year

Benefits :

- Cell phone reimbursement
- Paid time off

Experience :

- Regulatory Affairs: 8 years (required)
- US - Canada Regulatory Market: 8 years (required)

Work Location: In person

📌 Assistant Manager - Regulatory Affairs (Ahmedabad)
🏢 Pharmaceutical Distributor
📍 Ahmedabad