Job Description:
Excellent Opportunity For Experienced candidates with Freyr solutions in their Global Operations, Delivery and Development Center (Freyr is a fast-growing, Global Regulatory Solutions and Services company and a specialist provider of Consulting , Operations & Technology Services )
Venue details:
Freyr Solutions
Level 4, Building No. H-08
Phoenix SEZ( Avance Campus) Back side of Cyber gateway
HITEC City 2, Gachibowli
Hyderabad 500081
India
Phone: +91 40 4848 0999
contact – Babitha
Landmark: Lemontree hotel
Walk-in Interview from 15th December 2015 to 18th December 2015 from 10 AM to 5 PM
Qualification: Mpharma/Bpharma
Desired Profile :
Master Degree in Pharmacy
2-3 years Industry Experience in Regulatory Affairs, preferably in Pharma.
Experience of Submitting, Registering and maintaining Product registrations with MOH particularly EU and Asia Pacific Region (APAC) e.g. Singapore, Malaysia and Hong Kong.
Knowledge of Regulatory requirements of ICH and of various agencies like EMA, European Countries and Asia Pacific Region (APAC) e.g. Singapore, Malaysia and Hong Kong etc.
Even the knowledge of ICH,
Experience in assembling product dossiers for submission to Regulatory Authorities.
Good technical writing skills.
Should have ability to read, analyze and interpret documents.
eCTD experience
Computer knowledge
To co-ordinate with the manufacturing site for arranging the GMP Certificates
To co-ordinate with the manufacturing site for arranging registration/re-registration samples (e.g. drug product)
To co-ordinate with manufacturing site and country managers/Health Authority to arrange CPP (Certificate of Pharmaceutical Product)
General understanding of databases and process(es) to request the above listed items
Excellent communication skills in order to co-ordinate with different stakeholders including Health Authority
Medical devices experience
Work Location: Hyderabad
Job Type : Full Time
Interested Candidates Can directly Walk-in with their Latest CV to the above mentioned Venue.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area: Other
Role Category:Other
Role:Other
Keyskills:
mpharma bpharma medical devices Regulatory cmc
Desired Candidate Profile:
Education-
UG: B.Pharma – Pharmacy, Pharmacy
PG:M.Pharma – Pharmacy, Pharmacy
Doctorate:Any Doctorate – Any Specialization, Any Specialization, Doctorate Not Required
Company Profile:
Freyr Software Services Pvt. Ltd.
Freyr is a full-service global Regulatory Solutions and Services Company and a specialist provider of Consulting, Operations & Technology Services.
Freyr exclusively focuses on the entire Regulatory value chain of Bio-Pharma (Innovators / Generics), Consumer Healthcare and Medical Device companies, globally.
Freyr is a trusted partner providing end-to-end multi-geo, multi-lingual Regulatory services across Top 20 global brands for 4 of the Global Top 5, Top 20 Fortune 500 and many fast growing Small/ Medium Pharma, Consumer Healthcare and Life Sciences companies.
Freyr is one of the few global companies to have pioneered specialized Centers of Excellence (CoEs) exclusively focusing on the entire Regulatory value-chain which are supported by rapidly growing global teams of 350+ Regulatory Professionals.
Freyr’s Global Operations, Delivery and Development Centers are ISO 9001:2008 & ISO 27001:2013 Certified.
Recruiter Name:Babitha
Website:http://www.freyrsolutions.com
Telephone:04048480999