Greetings from CIEL HR SERVICES:
We have urgent Hiring for MEDICO REGULATORY
Location : Hyde
Someone with medical background preferably MD Pharmacology with 1-2 years of experience in
Medical writing(Regulatory writing) and ideation and differentiation or MBBS with 5-6 years of
relevant work experience.
Educational & Experience:
M Pharm with 6-8 years (OR) MD Pharmacology with 1-2 years of experience in pharmaceutical industry with exposure to regulatory authorities in various countries in Emerging Markets
Kindly check JD below Interested candidates drop your profile to email@example.com
Any quries please call / watsup @ 6303373434
Role Team Member (Medico-Regulatory)
Role Band R1B
Reporting To Lead Medico Regulatory
Location : Hyderabad
Research and Understand Scientific Requirements:
Consult with Clinical, Regulatory, Medical Affairs & Medico-Marketing team to understand the nature of the scientific work to be covered; Evaluate and Analyse data or products using the medical expertise, and conduct comprehensive literature searches covering all phases of drug development in order to enhance background understanding required for product registration.
Write, Review and Edit Scientific & Commercial Medical Writing:
Compile, Write and Edit medical writing deliverables covering all phases of clinical research for submission to regulatory agencies; Help write studies for submissions to the regulatory bodies; Develop and write pharmaceutical training materials and presentations in order to be used by a variety of stakeholders like RA Team, Regulatory Bodies, Clinical Team, Medico Marketing Teams
Support Regulatory Dossier Preparation:
Preparing and reviewing regulatory dossiers (Schedule Y, CT waiver, bio waiver, Medical rationales and Dossiers) for India, Russia, China, South Africa, Columbia, Algeria, and CIS, ASEAN and LATAM countries as per the country specific regulatory requirements.
Preparing and reviewing CTDs(Common technical documents Module 2,4 &5) and ACTDs, For EU/ Australia/Ukraine/ Kazakhstan/ Myanmar/Venezuela and Vietnam/ Singapore/Philippines.
Preparing and reviewing of Summary of Product Characteristics (SPC), Package Insert (PI), Package Information Leaflet (PIL), for India, ANZ, and Emerging markets depending on recommendations from the regulatory authorities and on global safety updates.
Preparing the presentations and documentation required for interface with regulatory authorities.
Comprehensive literature research to ideate new products, differentiated/ complex generics products for India and Emerging market along with the cross functional teams. Understand the unmet medical need in the different therapy areas in order to analyse the data available.
Stay Current with Medical Literature and Advancements:
Keep Track of current industry practices and regulatory requirements that affect medical writing; Keep Abreast of current literature, emerging science, technological developments and medical trends; Write summaries and maintain files on informative medical and scientific journal articles
Key Personal Attributes:
Ability to analyse data
Attention to Detail
Ability to lead projects independently.
Ability and willingness to acquire new skills.
Regulatory guidelines for different countries,
Knowledge of Medical writing,
Ability to communicate scientific or medical information in a clear and concise manner
Regulatory inputs for clinical development plans
Familiarity with the principles of clinical research
Ability to interpret and present clinical data and other complex information
Internal - Regulatory Affairs Team, Strategic Clinical Development Team, Clinical Operations, Toxicology team, PV team, Medico-Marketing, Packaging Team
External - Interacting with Regulatory Authorities of different countries, KOLs