The position is within our clients – Infectious Disease Emerging Markets. This job description will be reviewed periodically and is subject to change by management.
The Specialist Regulatory Affairs provides a support role to the Business Unit Manufacturing Site and key project activities. The Specialist Regulatory Affairs reports to the Associate Director Regulatory Affairs (manufacturing sites), IDEM. The role is based in Galway, Ireland.
This is an individual contributor position to support legal manufacturing site activities. As the experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports
Duties & Responsibilities
- Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications.
- Coordinates with cross functional teams including but not limited to: Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to product release.
- Serves as regulatory liaison throughout product lifecycle.
- Maintains strong communication and working relationships with all departments across division sites, Third Party Manufacturers, suppliers, and external personnel.
- Provides input and comment on regulations and standards which may affect division products
- 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.
- Develop and maintain strong and effective relations with internal/external personnel.
- Other duties as assigned, according to the changing needs of the business.
- Experienced professional individual contributor that works under limited supervision.
BASIC QUALIFICATIONS | EDUCATION:
- Minimum of a Bachelor’s Degree (BA/BS) from an accredited University
- Minimum of 1-5 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 able to productively generate quality documentation to meet Program timelines
- 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 confidential discussion and more information on this role please contact Chris O Toole