Manager - Regulatory Affairs

Immuneel Therapeutics Pvt. Ltd.; Bengaluru; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Immuneel Therapeutics Private Limited invites applications for a Manager - Regulatory Affairs. The role centers on regulatory CMC and operations, handling day-to-day regulatory activities and guiding the team through regulatory perspectives.

It requires liaising with CDSCO, maintaining records, and ensuring lifecycle compliance for cell therapy products. Ideal candidates have 10–15 years in regulatory affairs, with strong knowledge of CTD, ICH, US/EMA requirements, and leadership abilities to

Qualifications

• Bachelor’s or higher degrees mentioned in biosciences relevant to regulatory affairs.

Responsibilities

• Handle routine regulatory submissions.
• Manage liaising with CDSCO Zonal and KDCD offices.
• Maintain regulatory records and archiving for correspondences.
• Oversee life cycle management of products and regulatory compliance.
• Involve early-stage development regulatory activities (pre-clinical and clinical).

Education

Master’s in biotechnology/ Biochemistry/ Microbiology

Doctorate in Biological sciences

Job description

Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. 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 start-up 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’s employees are integral to our quest to develop and deliver high quality engineered cell 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.

1. Role Title:

Manager - Regulatory Affairs

2. Department/Function:

- Regulatory Affairs (CMC and Operations)

3. Reporting Structure:

• Reports to: Regulatory Affairs
• Direct Reports: NA

4. Role Summary:

This role requires knowledge about Regulatory CMC and operations. Understanding of regulatory milestones during the product development cycle. Understanding of regulatory procedures and guidelines. Understanding of product development cycle. Understanding of Life Cycle Management activities of the product. Understanding of liaising procedures with CDSCO Zonal and KDCD offices.

Its primary purpose is to take care of the day-to-day regulatory activities, guide the internal and CFT team members about possible regulatory perspective.

5. Key Responsibilities:

• Handle routine regulatory submissions.
• Manage liaising activities with CDSCO Zonal and KDCD office.
• Maintain regulatory compliance w.r.t. life cycle management of the products.
• Handle all early-stage development regulatory activities i.e. pre-clinical and clinical.
• Be responsible for maintaining regulatory records and archival for all regulatory correspondences.

6. Primary Objectives:

• This role is an intermediary role that should guide the junior team members and take ownership of routine activities.
• This role will help in maintaining higher standard of regulatory compliance.
• This role will also have strategic responsibility to establish and maintain good relationships with different regulatory agencies operating at state and zonal level.
• Regulatory know how about product development activities and corresponding regulatory expectations.
• Should be thorough with CTD preparation, ICH, NDCT rules, D&C act knowledge.
• Understanding of global regulatory requirements such as US and EMA for Biological products.
• Soft Skills:
• Good written and verbal communication
• Adaptable
• Team Player
• Self-motivated
• Persistent
• Strategic Thinker
• Hard-working
• Continuous learner

8. Qualifications:

• Desired - master’s in biotechnology/ Biochemistry/Microbiology
• Preferred – Doctorate in Biological sciences
• 10 - 15 years of experience in regulatory affairs

9. Working Conditions:

• Role Type: Full Time and Onsite
• Work Hours: General Shift or Rotational Shift
• Travel Requirements: Yes, 10 % travel (local)