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Most Urgent Vacancy for Regulatory Affairs--US Market-Navi Mumbai

Keywords / Skills : RA, Regulatory affairs, US Formulation

3 - 4 years
Posted: 2018-04-16

Pharmaceutical/ Biotechnology
Regulatory Affairs Executive
Posted On
16th Apr 2018
Job Description
Co-ordination with F&D, AMD, QA, QC & Production department for technical data required for registration.(US)

Review of master documents such as BMR, BPR and other analytical related documents required for submission.

Preparation and submission of DMF to Customers and regulatory Authorities

.Review of Change Controls and Deviations.

Review of BA/BE study related data such as ICF, CRF, Validation Protocols, Validation Reports study protocols, study reports etc.

Review of SOP, STP, MVP, MVR, and BSP related to study.

Conduct internal audits to comply with quality standards.

Hands on experience of working on HPLC, GC and other instrumental techniques.

Desired Candidate Profile

Candidates should be a Male person.

Should be into Formulation

dealing into US Market.

About Company

2COMS consulting Private Ltd. started operations in 1999 as a recruitment and staffing solutions company and since then has been successful in placing 5000+ candidates in the top IT and ITES companies.

2COMS has come a long way in a short time span of 6 years, expanding its business from Calcutta to other hubs and increasing its network ever since. At present, 2Coms has offices in Calcutta, Pune, Hyderabad, Siliguri, Guwhati, Jamshedpur and Bhubaneshwar propelled by a team of 60 trained consultants having the right combination of expertise and passion for achieving results making them deliver their best and achieving managerial excellence.

2COMS focuses on verticals like KPO / BPO / IT / Insurance, Banking and Finance / Telecom and Retail Pharma / Sales.

2COMS offers its clients end to end recruitment solutions tailor made to suit all kinds of manpower requirements.

Since its inception, 2COMS, with its domain expertise, enhanced business performance combined by focused insight and innovation, has gained a sound reputation amongst companies in businesses across all industries.

By Formulating effective strategies, we have gained a sound reputation of a premier staffing and recruiting Company, enabling us to attain the leading position in the industry. We are the preferred recruitment partners tomost of our clients. 2COMS efficiently services large-scale recruitment needs of its clients by its focused and integrated approach of flexibility, effective strategy, business expertise and powerful research capabilities.
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