Job Opportunities

Clinical Regulatory Affairs Assistant

Experience – 5 to 8 years
Location : Mumbai, Pune

Key Responsibilities:

  1. Overseeing regulatory submissions*: Ensuring that regulatory submissions, including Module 2.5 and 2.7, are accurate, complete, and compliant with regulatory requirements.
  2. Clinical data analysis*: Analyzing clinical data to identify trends, issues, and opportunities for improvement.
  3. Regulatory strategy development*: Developing and implementing regulatory strategies to support product development and approval.
  4. Collaboration with cross-functional teams*: Working with cross-functional teams, including clinical development, medical affairs, and regulatory affairs, to ensure alignment and compliance.
  5. Ensuring compliance*: Ensuring that all regulatory submissions and activities are compliant with relevant regulations and guidelines.

Requirements and Skills:

  1. Regulatory expertise*: Strong knowledge of regulatory requirements and guidelines, including ICH, FDA, and EMA.
  2. Clinical expertise*: Understanding of clinical trial design, conduct, and analysis.
  3. Analytical skills*: Ability to analyze complex data and identify trends and issues.
  4. Communication skills*: Excellent written and verbal communication skills, with the ability to effectively communicate with regulatory agencies, stakeholders, and cross-functional teams.
  5. Leadership skills*: Ability to lead and manage teams, prioritize tasks, and make strategic decisions.

Goals and Objectives:

  1. Successful regulatory submissions*: Ensuring successful regulatory submissions and approvals.
  2. Compliance*: Ensuring compliance with regulatory requirements and guidelines.
  3. Product development*: Supporting product development and approval.
  4. Risk management*: Identifying and mitigating risks associated with regulatory submissions and approvals.

IT Manager

Minimum 10 to 15 years of experience in pharma industry, should be well versed with progen ERP software, TrackNtrace software, Cyber security, IT risk management, Network administration, IT Infrastructure management & Security devices like Sophos Firewall, End to End Security, Linux Operating System, Windows Server Operating System & Acronis Backup Solution. Candidates should have good exposure in documentation like SOP preparation and support for CSV & Qualification. Handling of SQL & MYSQL database and queries.

IT Executive

Minimum 3 to 5 years experience of handling IT infrastructure and networking. Candidates should have good knowledge of User Support, Handling of WiiFi Routers, Switches, Firewall, Windows Operating System & and maintaining backup logs. Handling of SQL & MYSQL database and queries.

Purchase Head

Preferred candidate profile: Candidates preferred from Reputed Pharma background
Senior Manager / Head Purchase (Mumbai ) procurement of pharmaceutical formulations , APIs and Packaging Materials, The position will be accountable for the entire procurement process.Sourcing Vendor development, Price negotiation and procurement. The position is based at Mumbai. Graduates with strong techno-commercial knowledge will be preferred.

Purchase Executive – Packaging Material (Pharma background only)

Job description

3-5 years of experience in sourcing and procurement of Packaging Materials, for Pharmaceutical industry. The position will be accountable for the entire procurement process of packaging material. Sourcing Vendor development, Price negotiation and procurement. The position is based at Mumbai – Sakinaka. Graduates with strong techno-commercial knowledge from reputed pharma background will be preferred.

Exports Executive – Pharmaceutical Industry

Job description:

  • To organize for all Pre- Shipment & Post Shipment Documents within a specific deadline, plan for effective shipping procedures and find the desirable transportation method with the aid of the customers.
  • Filing and maintaining accurate records for all export transactions
  • Provide applicable export documentation needed by each country of destination
  • Ensure that export laws and regulations for export consignments payment terms are adhered
  • To submit timely document directives to independent surveyors and freight forwarders to necessitate timely processing of exports
  • Maintain up-to-date export files in a structured and catalogued system
  • Strategically plan and manage logistics, warehouse, transportation and customer services
  • Direct, optimize and coordinate full order cycle
  • Keep track of quality, quantity, stock levels, delivery times, transport costs and efficiency
  • Resolve any arising problems or complaints
  • Supervise, coach and train warehouse workforce
  • Meet cost, productivity, accuracy and timeliness targets
  • To analyze and negotiate shipping cost with freight forwarders and CHA on the basis of weight and consignment volume. Provide advice on the most affordable mode of transport to facilitate cost effectiveness
  • Check inbound documentation for accuracy prior to reception and intimate receiving documentation with shortages, overages and damages
  • Confirm barcode labels are applied on the shipper before dispatch
  • Coordination with internal department for export purpose
  • Prepare Sales orders in ERP system on time
  • Apply and coordinate with banks for e- BRCs.

Regulatory Affairs Executive – Pharmaceuticals

B.Pharma / M.Pharma candidates with 4-8 years experience in Regulatory Affairs for Asia & Africa, CIS markets & ROW market wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle.

Preferred candidate profile : Candidates from Reputed pharma background

Plant Head – (Pune)

Candidate with minimum 20 Years of experience in pharmaceutical company.

HR – (Pune)

Candidates with minimum 6 to 7 years of experience.

ARDL Department- (Pune)

Candidate with 3 to 4 years of experience in ARDL documentation work. should be well versed with HPLC & Method validation.

Exports executive – (Mumbai)

Candidates with minimum 10 years experience, well versed with exports documentation.

R&D Manager- (Pune)

Candidate with 10 to 12 years experience of R&D Department in pharmaceutical.

Sr. Account Executive – Mumbai

Experienced candidate having 6 to 7 year of experience, He should have knowledge of Income Tax for Companies as well as personal and GST knowledge for filing GST returns etc.

Receptionist – Mumbai

Experienced candidates with good communication skills and administrative abilities to handle the telephone , the manage the reception desk and co-ordinate travel arrangements for the staff .

Sales Representatives – Mumbai

Minimum 2 years’ experience in selling pharmaceutical OTC products in Mumbai. Qualifications – Graduate.

Area Manager – Mumbai

Minimum 2 years’ experience as Area Manager, in selling pharmaceutical OTC products in Mumbai and handling a team. Qualifications – Graduate. Preferably Graduate in Science.

Brand Manager – Mumbai

Minimum 2 years’ experience in Marketing and Sales, in selling pharmaceutical OTC products. Qualifications – Graduate.

Sales Analytics Executives – Pune

Experienced candidates in Sales Data Analysis.
Well-versed in Microsoft Excel with good communication skills and analytical skills.

BDM / Executives for Exports – (Mumbai / Pune offices)

Work Experience 2+ Yrs

Qualification Graduate / MBA in Sales and Marketing or Bachelor’s degree

Primary Skills

1.ExportMarket & competitor analysis.
2. Reviewing the market response and share with the Management to achieve market demands.
3. Developing prospective clients and interacting with existing clients for business
4.Tracking orders & payments from clients and market outstanding.

Manager – Generic Business (Domestic Market)

Candidates with experience of 5-7years in developing generic business in the domestic market with good contacts with generic distributors.

International Business Development / Marketing Executives

Candidates with 2-3 years’ experience in pharmaceutical companies with the ability to coordinate with various customers and branch offices, study and analyze market trends, maintain close contact with International Distributors, quick grasp of products/ applications, initiate and implement the marketing strategy to enhance the market share identify and develop new avenues for revenue growth and maintaing relationships with customers to achieve repeat / referral business. Travel overseas and interact with the associates and develop new customers.

International Business Development Managers – Africa and South Asian Countries

Candidates with experience in pharmaceutical Business Development for Africa and South East Asian countries for developing new customers and consolidating existing business. Ready to travel overseas and interact and appoint new distributors; identify new business opportunities to ensure growth in business both in terms of new products and customers.

QC-Chemical And Instrument Testing – (Surendranagar, Gujarat)

Candidates with having minimum 1-2 years experience in QC department (B. Pharm)

QA-Manager – (Surendranagar, Gujarat)

Candidates with minimum 8-10 years experience in pharmaceuticals QA department.(B. Pharm)

IPQA (In Process QA) – (Surendranagar, Gujarat)

Candidates with minimum 2 years experience in pharmaceuticals IPQA department (B. Pharm)

Microbiologist – (Surendranagar, Gujarat)

Candidates with minimum 1-2 years experience or freshers.(B. Pharm)

Assistant Manager Purchase – (Mumbai / Pune offices)

with 5-6 years and 2-3 years of experience in sourcing and procurement of pharmaceutical formulations , APIs and Packaging Materials, The position will be accountable for the entire procurement process.

Sourcing Vendor development, Price negotiation and procurement. The position is based at Mumbai. Graduates with strong techno-commercial knowledge will be preferred.

QA Manager – (Pune)

Candidates with 5 to 8 years of experience in pharmaceuticals QA department.

QC Dept. – (Pune)

Candidates with having minimum 3 To 4 years of experience of handling HPLC.

HR Head – (Pune)

Candidates with 15 to 20 years of experience in IR and HR.

Production head – (Pune)

Candidate with 10 Years of experience in pharmaceutical company.

Packing Officer (Pune)

Candidates with 2 to 3 years of experience in pharmaceutical company.

Sr. Manager regulatory- (Mumbai / Pune offices)

Candidate with 10 Years of experience in pharmaceutical regulatory department.

Artist – (Mumbai)

Candidate should be well versed with pharmaceuticals packaging designing. Experience in pharmaceutical companies required.

Assistant manager PPIC – (Pune)

Candidate with 8 to 10 years experience of PPIC in pharmaceuticals.

R&D Department- (Pune)

Candidate with 2 to 3 years of experience in R&D documentation work.

Officer Regulatory Affairs – (Mumbai / Pune offices)

B.Pharma / M.Pharm candidates with 2-3 years experience in Regulatory Affairs for Russia & CIS markets wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle.

Senior Executives Regulatory Affairs – (Mumbai / Pune offices)

B.Pharma / M.Pharm candidates with a strong experience 5-7 years in Regulatory Affairs for Russia & CIS markets wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle

ARDL Senior Executives –(Pune)

Candidates with 5-6 years experience in method development, validation & stability and documentation .Candidate should be from ADL background only for formulations and well versed in

  • Analysis of drug product i.e. Oral sold dosage forms, Liquids, topical and injectable.
  • Analytical method validation including designing of study protocol.
  • Handling major analytical instruments like HPLC, IC, GC etc.
  • Analytical method development for assay, related substances
  • Operating 21 CFR control system and all GLP requirements.
  • Handling regulatory deficiency related to analytical work

Manager QC – (Pune)

Candidates with having 10 to 15 years of experience in QC Department.