Pharma Regulatory Affairs Manager

Job Description Pharma Regulatory Affairs Manager

Location:

Job Overview

Pharma Regulatory Affairs Manager

Key Responsibilities

• Develop and implement regulatory strategies to ensure compliance with

  international and regional regulations

  .
• Prepare, review, and submit

  regulatory documents

  in line with global requirements (US, EU, and emerging markets).
• Liaise with

  regulatory authorities

  to address queries and obtain timely approvals.
• Monitor evolving

  regulatory guidelines and industry trends

  , assessing their impact on product development and commercialization.
• Partner with

  R&D, Quality, Clinical, and Legal teams

  to provide regulatory insights throughout the product lifecycle.
• Support documentation for

  clinical trials

  , including protocols, investigator brochures, and informed consent forms.
• Conduct

  risk assessments

  and provide recommendations for safety reporting and compliance obligations.
• Participate in

  audits and inspections

  , driving corrective and preventive actions as needed.
• Provide

  regulatory training and guidance

  to internal stakeholders to enhance compliance awareness.

Qualifications & Requirements

• Education:

  Bachelor’s degree in Pharmacy or a related scientific field (Master’s preferred).

• Experience:

  7 - 8 years in pharmaceutical regulatory affairs within a global organization.
• Strong knowledge of

  FDA regulations (21 CFR Part 11), ICH guidelines, EMA, and regional market requirements

  .
• Demonstrated success in

  regulatory submissions

  leading to product approvals.
• Proven

  project management skills

  , with the ability to manage multiple projects in a dynamic environment.
• Excellent

  written and verbal communication skills

  for engaging internal teams and external authorities.
• Strong

  analytical, problem-solving, and decision-making

  abilities.
• Proficiency in

  regulatory information management systems

  and related tools.