We have 2 openings as given below:
1. Regulatory Affairs Manager (ROW Markets)
We are urgently hiring for Manager Regulatory Affairs for a fast growing Pharma co. for their HQ located at Chandivali, Mumbai . Please find the details below:
Company Name: Fast Growing Pharma Co.
Requirement: 1 Nos.
Job Location: Chandivali, Mumbai
Designation: Manager Regulatory Affairs
Education: B.Pharm/ M.Pharm
Experience: 10-15 years experience into Pharma Regulatory
Industry: Pharma/ Biotech
Function Area: Regulatory Affairs
Key Skills: ROW, CTD, ACTD, pharma regulatory affairs, RA, manager, formulation
Salary Range: 10-12 Lacs per annum
· Experience in compilation, review and submission of CTD dossiers to foreign drug agencies in ROW markets as well as general laisoning with the local FDA.
· Interacting with the R&D centre as well as respective manufacturing sites.
· Overall responsibility for timely submission of dossiers to the company’s foreign branches as well as replies to the concerned foreign agencies.
· Responsible for the company to maintain its local GMP and product licenses from the Maharashtra FDA and the CDSCO.
· Write high quality deficiency response to various regulatory authorities.
· Knowledge of commercial regulatory requirements for all the regulated markets.
· Should have knowledge of registration process , plant audits.
· Compilation & review of dossier including technical data package.
· Review of Batch records, specification, art work, and packaging material, analytical method validation documents, development documents, PDR and labelling.
· Must also have knowledge of about ROW market and other market from dossier preparation and query solving point of view.
· B.Pharm and/or M.Pharm graduate.
· Have 10-15 experience in regulatory and/or quality assurance.
· well versed with the FDA & CDSCO online portal
· well versed with the drugs & cosmetics act, in particular Schedule M & WHO guidelines.
· Male Candidates preferred
2. Product Manager (Ortho/ Food Supplements), Andheri West Mumbai
We are urgently hiring for a Product Manager for a fast growong pharma co. for their HQ located at Andheri West, Mumbai. Please find the details below:
PRODUCT SEGMENTS: ORTHO / FOOD SUPPLEMENTS
Position: Product Manager
Location: Mumbai (5 days working)
Qualification & Experience: B.Pharm/ B.Sc or M.Sc + MBA with 3 to 7 years experience into PMT
Age: 27 - 35 years
• To promote, position & market existing Brands of our Rx division
• To be able to create marketing concepts for different products
• Identify and create a right positioning for the product and train the field force to ensure correct communication to doctors
• Ability to take training sessions of new field recruits
• New Product development
• Create various marketing material and compile product information
• Habit of field working and demonstrating strategy implementation
• Utilizing the learning from field work in designing future tactics and strategies
• Brand building, Marketing Strategy Planning
• Training Field Force, Motivating them
• B.Pharm/ life sciences graduate & MBA / B.Sc.-M.Sc.
• Hard worker with good market knowledge
• Self starter with Initiative and Result Oriented Leader
• Positive Attitude
• Good Communication &Good Documentation skills
• Good Analytical & Interpersonal Skills
• Committed & Ambitious Person who would be ready to take challenging responsibilities
• Experience in a similar industry with Rx marketing and brand management
• Proficiency in using Word, Excel and Power point
CTC range: Rs. 5 to 8 lacs per annum
If the position interests you, please email your cv at
aspsol.recruitments [at] gmail . com
with details on current CTC, expected CTC and notice period
Please refer the given job description for detailed information
Aspiring-Solutions is a passion driven and one stop over HR consulting services based in... Mumbai. We undertake bulk operations and specialize in undertaking all level recruitments inorder to cater the needs of different companies. Our motto is to provide quality candidates so as to meet the set expectations of our clients. Read full description