Specialist- Commercial Regulatory Affairs

Pall Corporation; New Delhi; On-site; INR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Comprehensive competitive benefit”s,包括

health‑care coverage and paid time off

Job summary

Pall Corporation in New Delhi, India seeks a Regulatory Affairs professional to coordinate with Business Units and regulatory authorities to secure registrations for medical devices and IVDs. The role emphasizes timely responses to queries and cross‑functional collaboration.

You will assess labeling, packaging changes, and in‑country testing data requirements, while guiding teams to maintain project timelines and quality standards.

Qualifications

• Degree in Science, Pharmacy, or a related field.
• 7–8 years of relevant experience in the registration process within the medical devices or IVD industry; well‑versed in India Medical Device Regulations2017 and amendments.
• Experience working in a matrix organization and international environment.
• Strong analytical and problem‑solving skills; interpersonal skills emphasizing diplomacy, negotiation, and teamwork.
• Effective communication skills, flexibility, self‑confidence, achievement‑oriented mindset, and a strong concern for quality.
• Experience handling projects with minimal supervision.
• Proficiency with MS Office and general IT literacy.
• Ability to multitask, prioritize, and meet project deadlines in a timely manner.
• Ability to work self‑directed to see issues through to completion.

Responsibilities

• Coordinate with Business Units Regulatory Affairs team to request necessary documents for applications.
• Respond promptly to queries raised by regulatory authorities regarding submitted applications.
• Ensure project timelines are met.
• Collaborate with cross‑functional departments to complete processes for products requiring in‑country testing data for registration purposes.
• Provide regulatory assessments for anticipated analytical, manufacturing, and packaging changes.
• Offer regulatory guidance for the preparation, review, and approval of labeling and promotional materials as needed.
• Recognize potential problems, including ambiguous situations, by actively reviewing and analyzing internal and external factors.

Skills

Analytical thinking

Problem-solving

Interpersonal skills

Negotiation

Teamwork

Education

Degree in Science or Pharmacy

Tools

MS Office

General IT literacy

Job description

ROLE

• Coordinate with Business Units Regulatory Affairs team to request necessary documents for applications.
• Respond promptly to queries raised by regulatory authorities regarding submitted applications.
• Ensure project timelines are met.
• Collaborate with cross‑functional departments to complete processes for products requiring in‑country testing data for registration purposes.
• Provide regulatory assessments for anticipated analytical, manufacturing, and packaging changes.
• Offer regulatory guidance for the preparation, review, and approval of labeling and promotional materials as needed.
• Recognize potential problems, including ambiguous situations, by actively reviewing and analyzing internal and external factors.

REQUIREMENTS

• Degree in Science, Pharmacy, or a related field.
• 7‑8 years of relevant experience in the registration process within the medical devices or IVD industry; well‑versed in India Medical Device Regulations2017 and amendments.
• Experience working in a matrix organization and international environment.
• Strong analytical and problem‑solving skills; interpersonal skills emphasizing diplomacy, negotiation, and teamwork.
• Effective communication skills, flexibility, self‑confidence, achievement‑oriented mindset, and a strong concern for quality.
• Experience handling projects with minimal supervision.
• Proficiency with MS Office and general IT literacy.
• Ability to multitask, prioritize, and meet project deadlines in a timely manner.
• Ability to work self‑directed to see issues through to completion.

BENEFITS

• Comprehensive competitive benefit programs, including health‑care coverage and paid time off.