Regulatory affairs specialist

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. For more details, please refer 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 ar
e: 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 els
e. Responsible and accountable : We demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performanc
e. 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-forwar
d. 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 value
d.
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 deliv
er.
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 capi
tal.
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 I
ndia. Interested to be a part of the next revolution in cancer treatment? Send your resum e to
l.com
1. Role
Title: Specialist - Regulatory Oper
ations
2. Department/Fu
nction: Regulatory
Affairs
3. Reporting St
ructure: Rep orts to: Re
gulatory Direct Reports: Individual Con
tributor
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 efficiency in regulatory processes. This role requires strong organizational skills, a high level of attention to detail, and the ability to collaborate across cross-function
al teams.
5. Key Respons
ibilities: Regulatory operations a
nd Liaison Review and submit regulatory documents, including Test licence No C, Import licence, IND and MA applications for cell and gene therapy products
to CDSCO. Represent immuneel for discussions and application with DCGI office,
New Delhi. Submission and follow up of RCGM submissions like form C3, Form C5 and liaise with RCGM and for meeting and
approvals. Liaise with ICMR, BIRAC and any other assigned allied departments for the regulatory process of the cell and gene therapy
products. Expertise in handling the online submissions of RCGM/SUGAM/NSW
S portals. Follow up of regulatory applications with CDSCO
and RCGM.
Governme
nt Affairs Liaison with Ministries and secretariats like Department of Biotechnology, Department of Pharmaceuticals, Ministry of Health, Ministry of finance and Ministry of Commerce and other ministries and secretariats a
s assigned. Establish working relationship, facilitate discussions and follow up with the above
ministries.
Regulat ory Affairs Work with site Regulatory Affairs and Quality teams for regulatory submissions and audi
t compliance
Regulatory
Intelligence: Stay updated on Indian regulatory requirements and changes in submissio
n guidelines. Stay updated in developers of CGT and the competitive intelligence of similar CGT product developm
ent in India. Communicate changes and their implications to relevant teams to ensure compliance with the site regulatory team an
d management.
6. Prima
ry Objectives: Represent Immuneel for regulatory interactions, regulatory applications, follow-ups and policy discussions with DCGI/CDSCO, DBT/RCGM, BIRAC, ICMR and Ministries and
Secretariats. Build and maintain a cordial professional relationship with regulatory offices a
nd ministries.
7. Compete
ncies Required: CDS CO Regulations: Deep understanding of the Drugs and Cosmetics Act, 1940, and related rules, guidelines, and circulars issued by the CDSCO. Drug Develop ment Lifecycle: Knowledge of the entire drug development process, from preclinical research to post-marketing surveillance. C linical Trials: Familiarity with clinical trial regulations, including Good Clinical Practices (GCP) and the New Drugs and Clinical Trial s Rules, 2019. Drug Ap proval Process: Understanding of the procedures for obtaining marketing authorization for new drugs, including dossier preparation a nd submission. Pha rmacovigilance: Knowledge of pharmacovigilance regulations and guidelines for reporting adverse d rug reactions. Medical Devi ce Regulations: (If applicable) Understanding of the Medical Devices Rules, 2017, and the regulatory framework for medical dev ices in India. Soft Skills: Liaison &am p; Negotiation: Ability to effectively communicate and negotiate with CDSCO officials, build rapport, and address their queries. Tec hnical Writing: Excellent writing skills to prepare clear, concise, and accurate regulatory documents, such as applications, submissions, and respons es to queries. Prese ntation Skills: Ability to present information effectively to internal and external stakeholders, including CD SCO officials. Inter personal Skills: Strong interpersonal skills to interact with colleagues, superiors, and external stakeholders in a professional and collab orative manner. Cri tical Thinking: Ability to analyse complex regulatory requirements and identify potenti al challenges. Problem-Solving: Ability to find solutions to regulatory issues and address queries from CDSC O efficiently. Atten tion to Detail: Meticulous approach to ensure accuracy and completeness of regula
tory documents.
8.
Qualifications: Educational
Qualification: Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, or
a related f
ield. Experience:10+ years of experience in regulatory operations, regulatory affairs, or
a related field. Extensive experience in liaison with DCGI, RCGM and other reg
ulatory offices.
9. Wo
rking Cond itions: 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 Sat urday or Sunday. Tra vel Requirements: No Base Location: Delhi (Currently, we have no office). Bangalore Office Location address - Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, B
angalore

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