Regulatory Affairs Manager

BKM Health Pvt. Ltd.; Ahmedabad District; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

BKM Health Pvt. Ltd. seeks an experienced Regulatory Affairs Manager for end-to-end regulatory submissions for US and Canadian markets, with a strong focus on oral solid dosage forms. The role requires ICH expertise, eCTD dossier prep, deficiency responses, and cross‑functional leadership to secure timely approvals.

The position entails leading submissions across US/EU/UK/Canada, mentoring staff, and maintaining the global regulatory tracking database in a compliant, timely manner.

Qualifications

• Bachelor's or Masters degree in Pharmacy or related field.
• 10–15 years of regulatory affairs experience for US/EU markets.
• Proven track record leading NDA/ANDA/NDS submissions through FDA review.

Responsibilities

• Plan, review and submit NDA/ANDA/NDS projects within timelines.
• Lead end‑to‑end regulatory strategies for product registration in US, EU, UK and Canada.
• Oversee preparation, review and filing of regulatory dossiers (NDAs, ANDAs, NDS, MAAs).
• Lead cross‑functional discussions to align submission strategies and timelines.
• Perform global regulatory due diligence and gap assessments for filings.
• Monitor evolving regulations and provide strategic guidance to ensure compliance.
• Handle regulatory queries and deficiency responses with agencies.
• Provide regulatory input on development programs, labeling and lifecycle management.
• Maintain and update global regulatory tracking database.
• Mentor and guide junior regulatory staff.
• Support due diligence for in-licensing and business development.

Skills

Regulatory leadership

Cross-functional collaboration

Regulatory strategy

eCTD authoring

FDA liaison

Education

Bachelor's/Master's in Pharmacy or related field

Tools

Lorenz docuBridge

Extedo

Veeva Vault RIM

FDA ESG

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)