Regulatory Affairs Specialist Immuneel Therapeutics Private Limited Bengaluru, Karnataka, India

About the job

About Immuneel

Immuneel Therapeutics Private Limited is a pioneering startup 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 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’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.

Interested to be a part of the next revolution in cancer treatment? Send your resume to careers@immuneel.com

Currently we are looking at the following role: -

Role Title: Specialist, Regulatory Affairs

Direct Reports: Individual Contributor

Role Type: Full-time

Base Location: Bangalore – 560099

Purpose:

The regulatory affairs (RA) is essential for obtaining approval for new drug/Investigational New Drug/other drug products and ensuring that approval is maintained till life cycle of the drug product. RA serves as the interface between the regulatory authority & program technical team and the channel of communication with the regulatory authority as the program proceeds, aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of RA to keep abreast of current legislation, guidelines, and other regulatory intelligence. The regulatory affairs (RA) play an important role in giving advice to the program team on how best to interpret the rules. During the development process sound working relations with authorities are essential, e.g. to discuss such issues as divergence from guidelines, the clinical study program, and product/ formulation development. Regulatory Affairs forms a bridge between drug regulatory authority and the pharmaceutical/Biopharmaceutical industry. It is a centralized function for communication of registrations, queries associated with a product in FDA as well as the ministry of health of various countries.

Key Responsibilities and Duties:

Overall monitoring of activities related to product registration, submission, and regulatory compliance.
Preparation, review and submission of applications and dossier/documents for registration in India and other regulated & semi-regulated countries, whichever applicable, as well as handling of queries raised by agencies and clients.
Technical writing, dossier preparation and compilation of the product dossier as per CTD format of Indian CDSCO and ICH or other national and International guideline
Develop and ensure documentation, tracking and archiving system for regulatory submissions.
Evaluate and review change proposals and coordinates domestic and internal regulatory and compliance response and requirements through change control system.
Keeping track of changing legislation in regions where the company distributes its products.
Interpret and apply regulations.
Advise internal colleagues on legal and scientific requirements.
Develop and implement regulatory strategies.
Collect, collate and evaluate scientific data.
Participate in product development programs to ensure adherence to international regulations and guidelines.
To give strategic and technical advice to R&D, production, QC department, Manufacturing, Clinical etc. right from the beginning of the development of the product, making an important contribution both commercially and scientifically to the success of a development program and a company as a whole.
Helping the company in order to avoid problems that may be caused due to improper scientific thinking or due to poor presentation of data
Additional duties as assigned by the supervisor.

Operating Network:

Interface with regulatory authority (Indian & Overseas), Quality Assurance, manufacturing, quality control, research & development, facilities & operations, environmental health safety and regulatory program for better compliance with regulatory requirements

Educational & Experience:

Educational Qualification – Ph.D, M.Tech., M.Pharm., M.Sc, in biotechnology / biopharmaceutical technology / biological sciences / quality and regulatory specialization; other advanced science degree (Masters) may be considered with relevant experience in regulatory affairs of biotech / biopharmaceutical products.
Based upon education, candidate should possess 12-16 years of previous experience in any biotech sectors including vaccine, biosimilars, gene and cell therapy is a strong plus.
Extensive Knowledge of IND application and MAA authorization of Indian & overseas regulation etc.
Experienced in regulatory science activity; technical writing, dossier preparation and compilation as per CTD format of Indian CDSCO and ICH or other national and International guideline
Knowledge in sterile manufacturing, GMP, GLP, GCP and GDP of various regulated (FDA, EMA) and domestic markets.
Understanding of quality assurance significance, cGMP and familiar with all relevant Regulatory guidelines (FDA, EMA, Schedule M, Y, CDSCO etc.).

Key Personal Attributes:

Desirable candidates should have the following abilities:

Proficiency in Microsoft Office skills (Word, Excel, PowerPoint, and Outlook)
Dynamic and dedicated with good communication skill and having mindset for growth and excellence.
Deep understanding of the regulatory requirements on the IND & MAA of biological product in India.
Able to perform complex tasks independently, self-motivated, engaged and organized.
Able to meet deadlines and harmonized with the organization vision and mission.
Ability to keep up to date on current regulations

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