Analyst / Specialist - Regulatory Affairs (CMC and Operations)

About Immuneel

Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India and the world. For more details, please refer www.immuneel.com

We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy.

Working at Immuneel promises the excitement of an agile startup on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work-life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are:

• Passionate in driving patient outcomes:

  We are passionately committed to doing the RIGHT thing to achieve the best outcomes for our patients through innovation, agility and performance orientation. We put the impact on the patient above all else.

• Responsible and accountable:

  We demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performance.

• Transparent, honest, and supportive in how we work together:

  We insist on integrity and respect for the individual. We demand excellence. Our performance management is focused on excellence through timely and constructive feed-forward.

• Inclusive and flexible:

  We are full of life and embrace all opportunities to collaborate and work together. We are excited about the collective knowledge and expertise that we share. “Being and thinking different” is valued.

Immuneel prides itself as an organization that is keeping pace with best practices in organization design. Our role-based organization incorporates global trends in human capital that promote focus on work and greater nimbleness. Our role-based structure allows you to be cherished by the work you do and bring value to your work rather than designations, our organization is simplified into a flat, non-hierarchical, millennial, organization where you may fully inherit the role you play in the organization and are recognized by the accountability you take and the work you deliver.

Immuneel’s employees are integral to our quest to develop and deliver high quality engineered cell and gene therapies in India. We believe that our culture provides an environment for employees to excel and find purpose. The strength of our team is every bit as important as our cutting-edge technology and we invest in clear compensation and comprehensive benefits for our employees. People for us, are not resources, but our capital.

If you are a talented professional, an out-of-box thinker with a zeal to help change, and passionate about healthcare, we invite you to join us and be a part of a historic initiative in India.

careers@immuneel.com

1. Role Title:

Analyst / Specialist - Regulatory Affairs (CMC and Operations)

2. Department/Function:

Regulatory Affairs

3. Reporting Structure:

• Reports to:

  Regulatory Affairs

• Direct Reports:

  Individual Contributor

4. Role Summary:

The ideal candidate will play a critical role in managing and supporting regulatory submissions, ensuring compliance with global regulatory requirements, and maintaining the highest standards of operational excellence in regulatory processes. This role requires strong organizational skills, a high level of attention to detail, and the ability to collaborate across cross-functional teams.

5. Key Responsibilities:

• Regulatory CMC and operations

• Prepare, review and submit regulatory applications , including but not limited to Clinical Trial Applications, IND, MA applications, Test licence NoC, Import licence applications, IND, IMPD for cell and gene therapy products to CDSCO and respective regulatory agencies in other geographies.
• Prepare, review and submit regulatory applications, including but not limited to Form B1, Form C3, Form C5 to RCGM. Any other regulatory compliance documentation related to RCGM.
• Prepare, review and submit regulatory applications, including but not limited to Form 27 applications, Form 30 applications, WHO GMP applications, COPP applications to KDCD. Any other regulatory compliance documentation related to KDCD.
• Should be able to manage all IBSC/GTAEC (if required) related assignments.
• Prepare, review and submit response to various queries received from CDSCO/RCGM/KDCD/Other regulatory agencies.
• Follow up for various regulatory applications submitted to CDSCO/RCGM/KDCD/Other regulatory agencies in terms of seeking acknowledgements, queries, response to queries and approvals.
• Expertise in handling the online submissions on RCGM/SUGAM/NSWS portals.
• Very well versed with CTD/eCTD requirements for M1, M2, M3, M4 and M5 of the dossier. And ACTD requirements for Part I, Part II, Part III and Part IV of the dossier.
• Should have understanding about the regulatory compliance with respect to life cycle management (LCM) activities and changes made to the approved products.
• Engage in cross functional activities such as audit management and compliance.

• Government Affairs

• Liaison with CDSCO Zonal Office (Bengaluru, Karnataka), KDCD, RCGM office, IBSC Committee as assigned.
• Establish working relationship, facilitate discussions and follow up with the above regulatory bodies.

Regulatory Intelligence

• Stay updated on Indian as well as Global regulatory requirements and changes in regulatory guidelines for Biologics and CGT products.
• Stay updated in developers of CGT and the competitive intelligence of similar CGT product development in India as well as globally.
• Communicate changes and their implications to relevant cross functional teams to ensure regulatory compliance.

6. Competencies Required:

• Technical

• CDSCO Regulations:

  Deep understanding of the Drugs and Cosmetics Act, 1940, and related rules, guidelines, and circulars issued by the CDSCO.

• Drug Development Lifecycle:

  Knowledge of the entire drug development process, from preclinical research to life cycle management (LCM).

• Clinical Trials:

  Familiarity with clinical trial regulations, including Good Clinical Practices (GCP) and the New Drugs and Clinical Trials Rules, 2019.

• Drug Approval Process:

  Understanding of the procedures for obtaining marketing authorization for new drugs, including dossier preparation and submission.

• Pharmacovigilance:

  Knowledge of pharmacovigilance regulations and guidelines for reporting adverse drug reactions.

• Behavioural

• Adaptable, Team Player, Collaborative, Empathetic, (Good) Listener, Persuasive, Ethical, Resourceful, Self Motivated, Result Oriented, Organised, Persistent, Conceptual, Information Seeker, Enthusiastic, Committed, Hard Working.

• Soft Skills:

• Liaison & Negotiation:

  Ability to effectively communicate and negotiate with regulatory officials/partners, build rapport, and address their queries.

• Technical Writing:

  Excellent writing skills to prepare clear, concise, and accurate regulatory documents, such as applications, submissions, and responses to queries.

• Presentation Skills:

  Ability to present information effectively to internal and external stakeholders, including regulatory agencies, cross functional teams and partners.

• Interpersonal Skills

  : Strong interpersonal skills to interact with colleagues, superiors, and external stakeholders in a professional and collaborative manner.

• Critical Thinking:

  Ability to analyse complex regulatory requirements and identify potential challenges.

• Problem-Solving

  : Ability to find solutions to regulatory issues and address queries from CDSCO efficiently.

• Attention to Detail:

  Meticulous approach to ensure accuracy and completeness of regulatory documents.

8. Qualifications:

Educational Qualification:

• Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, or a related field.

Experience:

• 2-5 years of experience in regulatory affairs (CMC + Operations), or a related field.
• Extensive experience in handling regulatory applications to DCGI, RCGM, KDCD and other regulatory agencies.

9. Working Conditions:

• Role Type:

  Full Time

• Work Hours:

  9:00 AM to 6:00 PM for the General Shift and 2:00 PM to 11:00 PM for the Post-Noon Shift (on a rotational basis). There will be two days off each week, which may not necessarily fall on a Saturday or Sunday.

• Travel Requirements:

  Occasional

• Base Location:

  Bengaluru.
• Office Location address - Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099