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!
