Job Description

Business: Piramal Pharma Solutions

Department: CRA

Location: Kurla

Travel: Moderate

JOB OVERVIEW: Preparation of licenses application & filing them on governmental portals for approvals from Indian regulatory authorities required for manufacturing, marketing and export of products in domestic and overseas markets by PPL sites in India.

KEY STAKEHOLDERS: INTERNAL: Manufacturing sites, R&D ,Program management, Supply Chain, Marketing, site regulatory

KEY STAKEHOLDERS: EXTERNAL: Govt. authorities like State FDA, CDSCO, FSSAI, CBN, NCB, custom officials, Customers etc

REPORTING STRUCTURE: (Reports To/ Direct Reports Y/N): Direct report to General Manager-RA

ESSENTIAL QUALIFICATION: Graduate

RELEVANT EXPERIENCE: >10 years

KEY ROLES/RESPONSIBILITIES: KEY ROLES/RESPONSIBILITIES:

Ø Registration Application on various Government portals (CBN, Sugam, FSSAI & XLN India) for new user Id’s creation.

Ø Follow up with State FDA Thane, CDSCO, FSSAI, NCB for grant of licenses

Ø Product Registration application in Form – 41 on DCGI Sugam Portal.

Ø Written confirmation (WC) application on DCGI Sugam Portal for API’s.

Ø Preparation & Online Submission for Import License application in Form – 10

Ø Preparation & Online Submission for CBN permissions (Import Certificates & Quarterly return filling)

Ø Preparation & Online Submission of API, RLD Test License Applications (Form–11 & Form CT – 17).

Ø Preparation & Online Submission of CDSCO permission in Form CT-11, CT-14 & CT-15, Dual Use NOC & Export NOC

Ø Preparation & Online Submission of application on state FDA portals like Test Licenses (Form– 29), wholesale license etc.,

Ø Preparation & Online Submission of various CBN application (Import/Export/Quota/Mfg. License).

Ø Quarterly return submission to CBN/NCB/State FDA

Ø Provide regulatory strategies and support all stakeholders w.r.t assessment of D&C Act

Ø Feedback on new guidance

Ø Review and assessment for selection of product for manufacturing at site as per the D&C act

Ø To create PR in SAP to process payment for various bills/Invoices received from consultants.

Key Competencies

written and spoken communications skills, cross functional collaboration, negotiation skills, meticulous planning and execution for timely receipt of approvals

Qualifications

ESSENTIAL QUALIFICATION: Graduate

About Us

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

About The Team

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.