Position: Lead Regulatory BLA and IND Expert

Job Type: CONSULTANT

Location: The role is based in Mumbai, with frequent travel to the US required. Candidates with a valid US VISA will be given preference.

Job Summary: -

The Lead Regulatory BLA and IND Expert will be responsible for leading the regulatory strategy and submission process for Biosimilar/Biotechnology products, including Biologics License Applications (BLA) and Investigational Current Drug (IND) applications. This role will play a critical part in ensuring compliance with global regulatory requirements and effective communication with regulatory agencies to support the successful approval and commercialization of biosimilar products.

Key Responsibilities

1. Regulatory Strategy Development:
- Lead the development and execution of regulatory strategies for BLA and IND submissions for biosimilar and biotechnology products.
- Provide expert guidance on regulatory requirements for biosimilar development, including comparability studies, clinical trials, CMC (Chemistry, Manufacturing, and Controls) documentation, and post-approval commitments.
- Serve as the primary regulatory contact for health authorities (FDA, EMA, etc.), managing regulatory meetings, inquiries, and negotiations.
- Oversee the preparation and submission of regulatory documents, ensuring compliance with global regulatory guidelines and timelines.

- BLA and IND Submissions:

- Lead the planning, preparation, and submission of BLA and IND applications, amendments, and supplements.
- Coordinate cross-functional teams (R&D;, Clinical, CMC, Legal, etc.) to gather and compile necessary documentation for regulatory submissions.
- Ensure the accuracy, quality, and compliance of all regulatory submissions, including CTD (Common Technical Document) format requirements.
- Maintain up-to-date knowledge of evolving regulatory landscapes, including new or revised regulations, guidelines,



and industry trends affecting biosimilar approvals.

- Regulatory Agency Interactions:

- Act as the primary point of contact with regulatory agencies (e.g., FDA, EMA) for BLA and IND submissions.
- Lead and coordinate regulatory meetings, including pre-IND, pre-BLA, and advisory committee meetings.
- Prepare briefing documents and lead the response to regulatory queries and deficiency letters.

- Regulatory Intelligence and Compliance:

- Monitor and interpret the evolving regulatory landscape for biosimilars and biotechnology products.
- Provide regulatory intelligence and guidance to internal stakeholders to ensure the company’s regulatory strategies are up-to-date.
- Ensure compliance with global regulatory requirements throughout the product lifecycle, from development through post-approval.

- Cross-functional Collaboration:

- Collaborate with clinical, non-clinical, CMC, and commercial teams to ensure alignment and integration of regulatory requirements.
- Support project teams in identifying regulatory risks and developing mitigation strategies.
- Provide regulatory training and mentorship to junior regulatory team members.

- Documentation and Systems Management:

- Oversee the creation and maintenance of regulatory documentation, including regulatory submissions, regulatory change control records, and regulatory filings.
- Ensure that all regulatory documents are managed, stored, and archived according to company procedures and regulatory requirements.




- Desirable Qualification and Skills Qualifications and Experience:
- Education:
- Advanced degree (Master’s or Ph.D.) in Life Sciences, Pharmacy, Biotechnology, or a related field.
- Professional Experience:
- 10+ years of regulatory affairs experience in the biopharmaceutical industry, with a focus on biosimilars and biotechnology products.
- Proven experience in leading BLA and IND submissions for biologics, including successful approval of at least one biosimilar product.
- Comprehensive knowledge of FDA, EMA, and ICH guidelines for biosimilar/biologics development.
- Experience in regulatory agency interactions, including face-to-face meetings, written responses, and submission follow-up.

- Technical Skills:

- Deep understanding of regulatory requirements for BLA/IND submissions, including CTD structure and eCTD publishing.
- Strong knowledge of biosimilar comparability studies, pharmacovigilance, risk management, and post-marketing safety reporting.
- Familiarity with clinical trial design, non-clinical studies, and CMC documentation for biotechnology products.
- Experience with regulatory information management systems (RIMS) and e-submissions.

- Soft Skills:

- Excellent project management and organizational skills, with the ability to handle multiple submissions and deadlines.
- Exceptional verbal and written communication skills, with the ability to present complex regulatory concepts to cross-functional teams and regulatory agencies.
- Strong leadership and mentoring capabilities, with a collaborative approach to problem-solving.

- Desired Competencies:

- Experience with global biosimilar approvals (e.g., EMA, Health Canada, PMDA).
- Familiarity with the regulatory environment for cell and gene therapy products.
- Experience with expedited regulatory pathways, such as Breakthrough Therapy Designation, Fast Track, and Priority Review

📌 Consultant -Lead Regulatory BLA and IND Expert (Mumbai)
🏢 BioSimilar Sciences India
📍 Mumbai