Freyr Software Services Pvt. Ltd Walk In Interview 2022 M.Pharma for CMC Regulatory Affairs -US, EU Markets At Hyderabad/Secunderabad. Freyr Software Services Pvt. Ltd Notification full details below..Interested and eligible candidates can attend interview on scheduled time and venue.
- Vacancy details:
- Post Name: CMC Regulatory Affairs -US, EU Markets
- Qualification: M.Pharma
- Experienced: 04 to 9 years of Experience
- Salary:₹ 9,00,000 – 16,00,000 P.A.
Job Description: Freyr Software Services Pvt. Ltd Hiring For CMC Regulatory Affairs -US, EU Markets !
- Important Details :
- Location: Hyderabad/Secunderabad
- Post of date: 14/03/2022
- Contact – Yasmin Mohammed ( 04048480999 )
- Selection Process: The selection will be on the basis of Interview.
- Interview Date:19th March ,
- Interview Time:10.00 AM – 5.30 PM
- Venue:Freyr Software Services Level 4, Building No. H-08 Phoenix SEZ Avance Campus Back side of Cyber gateway, Beside Dell Office HITEC City 2, Gachibowli Hyderabad 500081 India
- If Candidates are interested to direct walk-in can come to the above mentioned address.
- Candidates who are interested to attend virtual walk-in please apply for the above position.
Job Description :-
- Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines throughout project lifecycle
- Prepare CMC responses to health authority questions during development, registration and product lifecycle
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
- Gap analysis and authoring of MAA for Generic drugs for EU , US & ROW countries
- Experience in handling dosage forms like, Orals, Sterile, Ophthalmic, Topicals, Inhalaers…
- Real time experience in handling the end to end registration procedures like CP, DCP, MRP, NP
- Experience in provide the regulatory pathways and strategic inputs for EU countries, US Market & ROW Markets
- Change control assessment and strategy preparation
- Expertise in preparation of post approval submissions like variations, Renewals for Eu countries
- Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned
- Establish and maintain sound working relationships with partners and customers
- Handling the response to HA queries
- Excellent communication skills
- Team management capability
Freyr is one of the largest global, Regulatory-focused solutions and services companies for the Life Sciences industry supporting, Large, Medium, and Small size global Life sciences companies (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar