The Associate Director Regulatory Affairs provides a support role to our clients Business Unit Manufacturing Site and key project activities. The Associate Director Regulatory Affairs reports to the Divisional Vice President (DVP) Regulatory Affairs. The role is based in Galway, Ireland.
This position will have a strong emphasis on driving improvements for data management systems at our clients sites. The Associate Director Regulatory Affairs core responsibility will be to lead the Regulatory Affairs functions across our clients manufacturing sites.
Responsible for maintenance and compliance with applicable Corporate and Divisional Policies and procedures.
Oversee processes involved with obtaining and maintaining product release authorization and release of product to specified geographies.
Engage with Notified Bodies and Competent Authorities to facilitate regulatory approvals of on-market products and new product introductions.
Provide technical leadership for key Global, Divisional or Site regulatory initiatives by working closely with RA, Manufacturing, Affiliates, Third Party Manufacturing Operations and/or Quality.
Provide technical leadership for site certifications and quality management system audits.
Coordinates with cross functional teams including but not limited to: US Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to product release.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.
Apply specialized knowledge to coordinate day-to-day work.
Collaborate with cross-functional global teams
Resolve more complex situations by applying demonstrated knowledge and skills generally acquired through job experience.
Analyze information to select appropriate options from defined alternatives.
Apply experience and judgment to make decisions or resolve issues within defined options or standard protocols.
Carries out duties in compliance with established business policies.
Other duties as assigned, according to the changing needs of the business.
Independently gather resources and information needed to complete projects.
BASIC QUALIFICATIONS | EDUCATION:
Minimum of a Bachelor’s Degree (BA/BS) from an accredited University
Minimum of 10 years of experience in a GMP / Biotech / Pharma / Medical Device/ IVD/ Regulated Industry.
PREFERRED QUALIFICATIONS AND COMPETENCIES:
Strong written and verbal communication skills
Demonstrated success in the GMP / Biotech / Pharma / Regulated Industry.
Ability to adapt quickly and effectively to shifting priorities.
Very strong attention to detail
Must be coachable and must follow written and verbal direction
Must be able to productively generate quality documentation to meet Program timelines
Flexible scheduling (if needed and advance notice is given)
Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint
General knowledge of Quality/Regulatory requirements in a medical device/ pharma/ biotech industry
Adaptability, Innovation, Initiative, Teamwork, Quality of Work, Commitment
For a more detailed discussion on the role and company please contact Chris O Toole.