Opportunity for Regulatory Affairs Executive at ADVANZ PHARMA-Apply before 30th May 2024


Website Advanz Pharma

About Advanz Pharma

Advanz Pharma has a comprehensive approach to addressing various medical needs across different therapeutic areas. Their focus on specialty, hospital, and rare disease medicines indicates a commitment to serving patient populations with unique and often complex healthcare requirements. By offering a diverse portfolio of innovative medicines, specialty generics, biosimilars, and originator brands, we aim to cater to a wide range of medical conditions.

Our coverage of therapeutic areas such as hepatology, gastroenterology, anti-infectives, critical care, endocrinology, central nervous system disorders, and rare diseases suggests a broad spectrum of medical solutions. This approach reflects a dedication to advancing healthcare and improving patient outcomes across multiple fronts.

Post: Executive – Regulatory Affairs UK/IE

Job Description

As ADVANZ PHARMA solidifies its position as the preferred partner for specialty, hospital, and rare disease medicines, we present an exciting opportunity for an Executive in Regulatory Affairs.

  • Renewals and Maintenance: Responsible for planning and preparing for renewals and annual maintenance of Marketing Authorizations (MA’s), ensuring compliance with regulatory requirements and uninterrupted product supply.
  • Change Management: Assess change requests to determine regulatory strategy and required documents for submissions, ensuring timely communication with stakeholders.
  • Approval Process: Oversee approval processes, promptly responding to requests for information and carrying out post-approval activities as per regulatory procedures.
  • Regulatory Obligations: Meet other regulatory obligations such as submissions of Article 61 (3) updates, MAH Transfers, PSUR, and Sunset clause applications.
  • Compliance and Training: Ensure adherence to departmental procedures, maintain up-to-date training records, and regulatory databases.
  • Continuous Improvement: Actively participate in continuous improvement initiatives and implementation.
  • Process Ownership: Act as process owners for specific regulatory procedures as delegated.
  • Inspection Readiness: Support line managers in preparing for health authority inspections.
  • Deviation and CAPAs: Ensure timely completion of assigned deviations and Corrective and Preventive Actions.
  • Entrepreneurial Spirit: Thrive in an entrepreneurial environment and take accountability for results.
  • Embrace Challenge and Change: Adopt a growth mindset approach towards challenges and changes.
  • Bias for Action: Demonstrate a bias for action and fast decision-making.
  • Company Values: Consistently embody company core values: Entrepreneurship, Speed, and Integrity.
  • Team Collaboration: Foster collaboration across all business functions with open, honest, and respectful cooperation.
  • Contribute to Workplace Culture: Contribute to making ADVANZ PHARMA a desired place to work.

Candidate Profile

  • Regulatory Training: Formal training in Regulatory Affairs.
  • Educational Background: Graduate/Post-Graduate in a science discipline, preferably life science/pharmacy.
  • Experience: Significant experience in life cycle management of pharmaceuticals in UK/IE/EU markets.
  • CTD and Module 1 Expertise: Proficient in CTD and Module 1 writing, review, and submission.
  • Safety Variation Submissions: Experience in safety variation submissions, including writing/review and handling RFIs.
  • Regulatory Guidelines: Good understanding of ICH and regional regulatory guidelines, with the ability to interpret and apply them independently.
  • Project Management and Communication: Proficient in project management and possess strong communication skills.
  • Personal Attributes: Pleasant personality with a collaborative approach, interpersonal skills, and a high level of team spirit.
  • Drive and Decision-Making: Demonstrate drive, urgency, and solution-oriented decision-making.
  • Values Alignment: Inspired by the company values of entrepreneurship, speed, and integrity.
  • Learning Agility: Display learning agility and scalability, with a desire for continuous improvement and development.
  • Work Environment Compatibility: Ability to thrive in a growing, unique, and inclusive work environment.

Additional Information

  • Qualification: M.Pharm, B.Pharm, M.Sc
  • Location: Mumbai
  • Industry Type: Pharma/Healthcare/Clinical Research
  • Functional Area: Regulatory Affairs
  • End Date: 30th May 2024

Please feel free to reach out with any questions or to apply for this exciting opportunity. We look forward to welcoming you to the ADVANZ PHARMA team!

To apply for this job please visit careers.advanzpharma.com.