Job Description

Assistant Manager / Manager Regulatory Affairs :

We are seeking a highly experienced Regulatory Affairs Assistant Manager responsible for end-to-end regulatory submissions for the US and Canada 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 the US, EU, UK, and 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, 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 / 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 (In office)

Pay: ₹800,000.00 - ₹1,300,000.00 per year

Benefits:

- Cell phone reimbursement
- Paid time off

Application Question(s):

- What's your Current CTC?
- What's Your Expected CTC and Notice period?
- Do you have hands-on experience with regulatory submissions such as NDA, ANDA, NDS, or MAA?
- Have you worked on regulatory dossiers, deficiency responses, or agency communications in US and Canada markets?

Education:

- Master's (Preferred)

Experience:

- Regulatory Affairs: 8 years (Required)
- US - Canada Market: 9 years (Required)

Shift availability:

- Night Shift (Required)
- Day Shift (Required)

Work Location: In person

📌 Assistant Manager - Regulatory Affairs (India)
🏢 BKM Health
📍 India