Assistant Exmanager Regulatory Affairs

From 3 to 8 year(s) of experience
- ₹ Not Disclosed by Recruiter
- Navi Mumbai, Pune, Mumbai (All Areas)**Assistant Manager Regulatory Affairs - Food/Nutrition/FMCG Industry**

**Assistant Manager Regulatory Affairs**

**Experience - 3 to 10 Years in the Chemical, Food/Nutrition/FMCG Industry**

**KEY RESPONSIBILITIES**
- Preparation & planning of submission of CTD/ACTD Dossier for Export markets. (CIScountries, Southeast Countries.
- Review of All Product documents as Batch record, Specifications, MOA,
- Validation Protocol and reports, Stability protocol and report for dossier
- preparation and compilation.
- Ensure that a company's products comply with the regulations of the regions/ respective authority where they want to distribute them.
- Keep up to date with national and international legislation, guidelines, and

customer practices.
- Collect and evaluate/ compile technical data from department at plant like

QC and QA.
- End to end evaluation and closure of the regulatory queries within

approved timelines.
- Develop and write clear justifications and explanations for new product

filings and renewals and variation filings.
- To work in close coordination with Site QC, QA and Regulatory Teams at

HO/ Corporate Office.
- Evaluation and impact assessment on updated regulatory requirements.
- To keep Status of regulatory inspections.
- Prepare site registration documents for export countries like Philippines FDA.
- Resolve the technical queries related to product registration / Re-registration & post approval changes.
- Follow up & co-ordinaion with internal stake holders (QA, QC,& PRODUCTION R&D)
- Review of technical documents (Processvalidation, stability data, Analytical method validation, PDR report, FPS, STP, BMR, BPR, COA, container closure system & Open part of DMF
- To initiate & review of BE STUDY from approved BE centre.
- Follow up &coordination with mfg. site for registration of sample /working standard & impurities requirement for lab analysis.
- Responsible for coordination with mfg. location for sample procurement & timely submission to Regulatory submission.
- To check the Art work & co ordinate with packaging development team.
- To write, check/review of documents as per regulatory requirements
- To publish with software submission documentation as per regulatory requirements
- To response to regulatory deficiencies letters according to EU and USA regulatory requirements.
- To support local in-licensing
- To collaborate with other departments/partners
- To maintain lists/documents/records
- To achieve his/her responsibilities within the agreed timescales
- To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating.
- To prepare weekly, monthly regulatory status report of new registration /re-registration /post approval changes& give feedback to Reporting Authority (Director ).
- Role:_Regulatory Affairs Compliance
- Salary:_ Not Disclosed by Recruiter
- Industry:_Pharmaceutical & Life Sciences
- Functional Area_Legal & Regulatory
- Role Category_Corporate Affairs
- Employment Type:_Full Time, Permanent
- Key Skills- Dossier PreparationfoodRegulatory AffairsGlobal Regulatoryfmcg- Marketing ResearchNutritionRegulatoryNew BusinessPharmaceuticalCTDManager RegulatoryFormulationingredientsDealingChemical SalesRegulatory ComplianceExport Market- Skills highlighted with ‘‘ are preferred keyskillsEducation
- PG:_M.Pharma in Pharmacy

**Company Profile**:
People Alliance Workforce Private Limited

People Alliance Workforce Private Limited

People Alliance Workforce Private Limited, founded in 2006 is a specialist local and international human Resources company with national coverage in PAN India & international provinces.

People Alliance Workforce Private Limited An ISO 9001:2008, QMS Certified ,TQM based And Indias largest multi interest consulting and business services corporation engaging a variety of organizations, institutions and enterprises in diverse industry. People Alliance is the Indias leader in innovative workforce solutions, creates and delivers highimpact solutions that enable our clients to achieve their business goals and enhance their competitiveness. With over 15years of experience. These solutions cover an entire range of talent-driven needs from recruitment and assessment, training and development, and RPO&HRPO, to outsourcing and

People Alliance Group began doing business in 2006, offering executive search and recruitment process outsourcing services to our clients. Several years later, we had a vision to establish a single organization that was able to vertically integrate all hiring solutions, a company capable of fulfilling all recruitment and retention needs as well as providing the resources to manage and enhance an organizations most valuable asset its people.

With much thought and preparation, this concept became a reality in June 2009, when People Alliance became. People Alliance Group. Sixteen offic