Regulatory Affairs Manager

2COMS Consulting Pvt. Ltd.
  • Gurgaon
  • 10-11 lakh
  • 10-15 years
  • Views
  • 17 Nov 2016

  • Medical Services

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Job Description

-To be a critical regulatory link between Corporate DRA and Manufacturing to collate, review and share the data for filing in different regions as per requirement of Corporate DRA to achieve timely filing of APIs
-To ensure regulatory compliance for exhibit batches at Toansa site, as required
-To provide support to other departments like Quality Assurance / Manufacturing / Quality Control to discuss regulatory impact of the change controls and during various Customer Audits at Toansa.
Level of Responsibility: Medium
Scope: DRA Bulk (Toansa)
1.To provide manufacturing end data of APIs to Corporate DRA for regulatory Filings in US, EU, Canada, Japan & Emerging Markets and APIs for Annual reportable Changes & post-approval changes for filing Amendments/Variations in US, EU, Canada, Japan & EM
2.Day to day regulatory support to API Manufacturing for review/approval of Change-Control for ensuring Regulatory Compliance
3.Regulatory Compliance reviews for API / Intermediates exhibit Batches, if required
4.To assist API Manufacturing during regulatory audits conducted by various regulatory agencies.
Delegation of Responsibility: In the absence of the job holder, the responsibilities will be delegated to a colleague at the same or higher level.

Job Profile:
1.To review the manufacturing end data of Exhibit Batches of New APIs as well as Post-approval changes of Existing APIs taken at Toansa for regulatory adequacy & provide to corporate DRA in a timely manner for various regulatory and customer filings and queries in a timely manner.
2.To review Change Controls pertaining to process, quality & equipment related matters and Q-Info extensions of Key Raw Materials/Key Reactants of various APIs manufactured at Toansa.
3.To ensure Regulatory Compliance of Exhibit Batches of APIs to be filed in DMF, ANDA batches, DMF Update / Amendment / Variation batches of Toansa.
4.To ensure data generation of API / Intermediates in line with approved protocol requirements & provides regulatory support during regulatory audits at various manufacturing sites of Sun Pharma.

Assessment and Planning of Work:
The job function primarily starts with the planning for data collation upon receipt of requirements from corporate DRA and based on the targeted dates for filing.
The person has also to ensure compliance of manufacturing end data with regulatory requirements/ commitments during commercial manufacturing for ANDA and Update batches.

For meeting the regulatory filing and Compliance objectives, the key internal contacts are as:
Corporate DRA (Bulk): Associate Director and his / her team this is primarily to discuss the filing requirements.
API (Manufacturing): General Manager/Sr. Manager and their teams this is primarily to discuss and obtain data for filing requirements viz., manufacturing process, equipment list with details and also to discuss regulatory impact of the change controls that they raise.
Quality Assurance/Control: Director/General Manager/Sr.Manager and their teams this primarily to discuss and obtain filing requirements viz., MPRs, executed BPRs, COAs, Stability data with details.

External: Not Applicable

Competencies Required:
Technical Competencies:
Basic Knowledge and awareness towards Regulatory requirements and guidelines to drive filing (fresh, deficiency responses, renewals/re-registrations and variations) in line with regulatory expectations
Basic Knowledge of quality guidelines,
Adequate knowledge of Microsoft (MS-word and MS-excel) for creation of checklist and internal SOPs for review and its implementation

Behavioral Competencies:
Good Interpersonal Skills
Effective Communication
Team work
Willingness to learn.

Competencies/Skill sets for this job

Quality Control Protocol Data Generation Sops

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About Organisation

2COMS Consulting Pvt. Ltd.