Regulatory Sciences & Affairs Professional

Location

Vapi | India

Job description

Greetings from Micro Crispr !!!

Micro CRISPR is a new age biotechnology company with an outlier mindset on a quest to improve millions of lives. We strive to lead with our core values and to help spread ideas of sustainability and responsibility whose impact can reach far beyond our own business.

You can find more details at

We are now venturing in a new direction of CRISPR / CAR T / mRNA were in we want to research in following direction

Cell Therapy & Gene Therapy

• Personalized CAR-T & Universal CAR-T Products

• Therapeutic CRISPR-based genome editing (Cell & Gene Therapy)

• CRISPR-based plant products (Improved varieties)

• Xenotransplantation by CRISPR-based methods.

• AAV and lentiviral vector therapeutic products

• Lipid nanoparticle-based therapeutic gene delivery

We are looking for passionate Regulatory affairs and DQA professionals willing to contribute in the field of Cell & Gene therapy using CRISPR / CAR T / mRNA based technology.

Role: Regulatory Sciences & Affairs

Job Description:

1. Devising regulatory CMC strategy and planning the submission for various biological products, new application & post approval variations (BLA, CTA, IMPD, IND, & MA) especially the early phase of product development.

2. Review and compilation of CMC data to appropriate standards & requirements to the various markets.

3. Provide interpretive analyses of regulatory guidance, regulations, or directives that impact product(s) or CMC operations.

4. Support CMC regulatory risk assessments and drives contingency planning and mitigation of identified regulatory risks.

5. Evaluation of internal documents for regulatory compliance and gap analysis.

6. Preparation, review and compilation of responses to regulatory queries.

7. Preparation / review of registration dossiers and variations / amendments / annual reports / renewals as applicable.

1. Authoring and reviewing the biological regulatory submissions by gathering the data.
2. Strong in national regulatory, ICH, and FDA guidelines, regulations, and monographs, analyzing technological advances and industry trend to advise the team in updated regulations.
3. Coordinating and tracking of regulatory activities involved with internal departments.

Requirements:

• M.Sc / M.Tech / M.Pharm any life-science disciplines with minimum 3-5 years of experience in any biologics / biosimilars regulatory sciences.
• Previous experience in process and analytical development, or bio manufacturing will be an added advantage.

· Proven record of successful authoring and contribution to delivering CMC sections of marketing authorizations for biologics.

• Knowledge of cGMP requirements and standard systems (e.g. change management systems and tools)
• Authoring and re-authoring IMPD/INDs and Module 3 for biologics.
• Sound understanding of ICH and major markets' regulations on biologics.
• Experience in communication with the Health Authorities on CMC matters

Collaborate with R&D, Manufacturing, QA, QC and other functions.

Note:- Only relevant experienced candidates may apply. Early joiners with 15 days Notice period will be preferred.

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