Job Vacancy in
Mission Pharma, Ahmedabad
JOB DESCRIPTION:
Position:
Officer -Regulatory Affairs
Qualification:
Pharmacist, Bachelor/Master in Pharmacy or Pharmaceutical Science.
Work experience:
5-7 years
Competences:
• Regulatory knowledge in handling pharmaceutical products.
• Aware about submission of CTD in different countries for ROW market.
• Knowledge on various regulatory guidelines on WHO, EU and ICH.
• Should be energetic and passionate about work.
• Ability to maintain positive attitude when under pressure and in stressful situations.
• Good administrative skills.
• Team player with good communication skills.
• Should be well structured and systematic.
Languages:
Proficiency in English is must.
Duties/Responsibilities:
• Responsible for coordination with supplier for arranging documents timely for dossier compilation.
• Responsible for preparation and dispatch of registration dossiers for pharmaceutical products as per application guidelines.
• Responsible for samples dispatch and to provide information to CM and agents.
• Responsible for evaluation, response preparation with supporting documents from supplier to query received from NDRA within deadlines.
• Concurrent follow-up with Country Manager, Agent and NDRA for ongoing submissions.
• Coordination with cross-functional dept. on regulatory assistance.
• Ensure all activities related to Regulatory Affairs (RA) complies with SOPs and regulatory requirements.
• Preparation of product layouts (labels, leaflets, SPCs) in line with regulatory guidelines pharmaceutical products.
• Proactive and dedicated work on product registration ensuring meeting deadlines.
• To support activities within team and collaborate on the development of strategies, execution of projects and ad hoc tasks.
Contact:
Praveen Rangari (9967223247)
Reference Bhardwaj
Pharma vacancy
