Sr. Regulatory Affairs Executive/Assistant Manager

BKM Health Pvt. Ltd.; Ahmedabad District; On-site; INR 1,500,000 - 3,200,000; Full time

Job summary

BKM Health Pvt. Ltd. in Ahmedabad, Gujarat, is seeking a Sr.

Regulatory Affairs Executive/Assistant Manager with 7–11 years of regulatory affairs experience in US/EU markets, for on-site work. The role focuses on leading NDA/ANDA submissions, global regulatory strategies, and cross-functional coordination to ensure timely approvals. The candidate will oversee dossier preparation, maintain regulatory records, and mentor junior team members while driving compliance with ICH guidelines and ESG/CESG

Qualifications

• 7–11 years of relevant Regulatory Affairs experience in regulated markets, particularly the US and EU.
• Demonstrated success in independently leading and managing multiple NDA and ANDA submissions through the full FDA review cycle.
• Strong knowledge of ICH guidelines, regulatory dossier preparation, eCTD submissions, and deficiency response management.
• Familiarity with FDA ESG and Health Canada CESG gateways.

Responsibilities

• Plan, review, and submit assigned NDA and ANDA projects within established timelines.
• Drive end-to-end regulatory strategies for product registration and approval across US, EU, UK, and Canada markets.
• Oversee the preparation, review, and filing of regulatory dossiers (NDAs, ANDAs, NDSs, MAAs).
• Lead cross-functional discussions to align submission strategies and timelines.
• Perform global regulatory due diligence and gap assessments to identify risks and mitigation plans across key regions.
• Monitor evolving regional regulations and provide strategic guidance to ensure compliance.
• Manage regulatory queries, deficiency responses, and agency communications.
• Provide regulatory input on product development, labeling, risk management, and lifecycle management.
• Maintain global regulatory tracking database for records completeness and accuracy.
• Mentor junior Regulatory Affairs team members and support professional development.
• Support due diligence for in-licensing and business development opportunities.

Skills

FDA submissions

Regulatory strategy

eCTD publishing

Cross-functional leadership

Education

Bachelor's or Master's degree in Pharmacy

Tools

Lorenz docuBridge

Extedo

Veeva Vault RIM

Job description

Sr. Regulatory Affairs Executive/Assistant Manager

Education: Bachelor s / Master s degree in Pharmacy or a related field.

Experience Requirement: 7 11 years of relevant experience in Regulatory Affairs for regulated markets (US/EU), with expertise in oral solid dosage forms.

Location: Ahmedabad, Gujarat (On-site)

Job Type: Full-time

Key Responsibilities:

• Plan, review, and submit assigned ANDA and NDA projects within established timelines.
• Drive end-to-end regulatory strategies for product registration and approval across US, EU, UK, and Canada markets.
• Oversee the preparation, review, and filing of regulatory dossiers, including NDAs, ANDAs, NDSs, and MAAs, ensuring 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 develop mitigation strategies for US, EU, UK, and Canada filings.
• Monitor evolving, region‑specific regulations and provide strategic guidance to cross‑functional teams to ensure compliance.
• Manage regulatory queries, deficiency responses, and communications with regulatory agencies.
• Provide regulatory strategic input on product development programs, labeling, risk management, and product lifecycle management.
• Maintain and update the global regulatory tracking database, ensuring the completeness and accuracy of regulatory records.
• Mentor and guide junior Regulatory Affairs team members to support professional development and team effectiveness.
• Support due diligence activities for in‑licensing and business development opportunities.

Required Qualifications & Skills:

• Bachelor s or Master s degree in Pharmacy or a related field.
• 7 11 years of relevant Regulatory Affairs experience in regulated markets, particularly the US and EU.
• Demonstrated success in independently leading and managing multiple NDA and ANDA submissions through the full FDA review cycle.
• Strong knowledge of ICH guidelines, regulatory dossier preparation, eCTD submissions, and deficiency response management.
• Advanced proficiency in eCTD authoring and publishing platforms such as Lorenz docuBridge, Extedo, Veeva Vault RIM, or equivalent systems.
• Familiarity with the FDA Electronic Submissions Gateway (ESG) and Health Canada Common Electronic Submissions Gateway (CESG).
• Strong cross-functional leadership, strategic planning, problem‑solving, and communication skills.