Opportunity for Group Leader-Regulatory Affairs, in a one of the top pharma company of India

[Yogesh Vishwakarma]

We are "iCresset Talent Solutions", an executive search firm, founded by IIM Alumni engaged in Talent Acquisition, Talent Assessment, Talent Development and Retention services for top notch organizations. (www.icresset.com , www.profilesinternational.in)

We are looking for Group Leader – Regulatory Compliance, professionals who are expert in the given below areas for our esteem client; who is one of the top pharmaceutical company in India.

Job Purpose:

To review and understand country specific regulatory guidelines like (US, EU & Latin American countries) and file Drug Master Files with the respective regulatory authorities within the timelines to achieve speedy approvals

Role & Responsibilities 

·         Planning and managing the activities of regulatory compliance division of DRA API at API mfg locations and contract mfg locations by conducting periodic audits.

·         Regulatory support to API manufacturing and QA at site. 

·         Interact with Chemical Manufacturing and QA for manufacturing end data for regulatory submission including responding to regulatory deficiencies

·         Review and approval of Change Controls (process, Spec/STP, new vendor, facility) and Variation management in consultation with Corporate DRA-API.

·         To ensure regulatory compliance of exhibit batches and generation of data in line with the approved protocol.

·         Review of manufacturing data for adequacy before regulatory submissions

Desired Profile:

Applicant should have thorough knowledge of regulatory guidelines as per the requirements of various Regions and should be well versed with GMP Requirements

Education:   M. Sc./ M. Pharm. /Ph. D in Organic Chemistry/ Pharmaceutical Chemistry

Experience:   9 -12 years of relevant experience

Competencies Required:

The applicant must have a keen interest in the area of Regulatory Affairs with zeal to deliver under stringent deadlines in addition to being a team player and having good communication skills. 

Job Location : Dewas (Madhya Pradesh)

Salary Package: Best in the industry and not a constraint for right candidates

Contact : If interested, please revert back to your updated CV to yog...@icresset.com

 

 

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With Best Regards:-

Yogesh Vishwakarma