HomeRegulatory AffairsSenior Research Scientist - Regulatory Compliance | Mankind Pharma | Manesar, Gurgaon

Senior Research Scientist – Regulatory Compliance | Mankind Pharma | Manesar, Gurgaon

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Mankind actively started operations as a fully-integrated pharmaceutical company in the year 1995 as a very small entity in Meerut with about 20 products, a team of 53 people, and an investment of ₹50 lacs. Today, Mankind has an employee base of over 14,000 and is racing towards $1 Billion with a vision to be amongst the Top 3 pharma companies of India.

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We take great pride in the success of our products ranging from Pharma, OTC and FMCG brands like Manforce Condoms, Manforce Tablets, Unwanted 72, Prega News, Adiction, Gas-O-Fast, Kaloree 1 and many others.

At Mankind, we recognize and value the diversity of our employees, their perspectives, and experiences. We take much pride in fostering an engaging and inspiring environment for all our employees. Keeping everyone connected with work, new initiatives, and with the organization in a productive manner to ensure the work-life balance and effective utilization towards the attainment of individual, group, and organizational goals.

The most differentiating factor leading to progress and morale boost is that we work as a team with the transparency to make the goals realistic & achievable. We offer the best working culture, nurture their talent, incorporate a strong culture of learning using interesting and latest techniques, and rewarding employees at every possible step of their journey.

Position: Senior Research Scientist – Regulatory Compliance

Location: Manesar, Gurgaon, Haryana, India

Job Description:

Roles and Responsibilities

  • Understanding on tracking regulatory commitments & regulatory reporting requirements
  • Understanding of post-approval changes & Life cycle management of approved ANDAs
  • Good understanding of quality function-related activities
  • Good understanding of plant generated documents like BMR, BPR, PPQ protocol/ reports, Hold-time reports, scale-up documents, general testing procedures, specifications, stability protocols/ data, analytical method validation protocols, and reports.
  • Coordination with various departments in plant, R&D, and outsourced partners
  • Exposure to procedures related to FAR/ ADE/ PQC/ Recall etc.
  • Exposure to Pharmacovigilance system will be a plus

Desired Candidate Profile

  • Candidate should have relevant regulatory experience in Regulatory Compliance for Oral Solids (OSD) and Sterile Drug Products (Injectable/ Ophthalmic/ Inhalation/ complex sterile products) for US/ EU/ other Regulated markets
  • Candidate should have approx. 6 10 years of relevant experience
  • Good understanding of regulatory guidelines of regulated markets

Qualification: M.Pharma

Experience: 7-12 Years

Salary: Negotiable

Contact Details: 

sachin.nair@mankindpharma.com, careers@mankindpharma.com

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