Regulatory Affairs Specialist II at Boston Scientific Corporation Malaysia

The Municipal District of Newcastle West, Munster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

20 Mar, 26

Salary

0.0

Posted On

20 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Pharmaceutical Compliance, Quality Systems, Submissions, Clinical Projects, Leadership, Organizational Skills, Communication Skills, Teamwork, Adaptability, Technology Proficiency, Local Regulations, Drug Development, Batch Variation Summaries, Customer Complaints, CAPA

Industry

Medical Equipment Manufacturing

Description

Review and assess design and CMC changes, and prepare suitable submissions to ensure compliance to pharmaceutical regulatory requirements. Support and provide regulatory input for pharmaceutical quality system deliverables such as batch variation summaries, customer complaints, CAPA, deviations, NCMR, etc. for the manufacturing site(s). Prepare and submit OPDP, NDA and IND submissions and annual reports using eGateway via third party providers for USA submissions. Support clinical, sustaining projects and other product focused teams by giving direction on regulatory impact and requirements for proposed changes. Establish and maintain effective relationships and professional interactions with manufacturing sites CMC and Quality staff, third party suppliers, regulatory authority staff and reviewers. Support filings and maintenance of regulatory files globally. Management of local site licenses for manufacture and importation. Participate in regulatory authority inspections and audits. Monitor regulatory landscape and communicate changes or new requirements that may impact the product or quality system. Degree in Life sciences (e.g., Chemistry, Biology, etc.). Minimum requirement of pharma industry experience 1-3years, ideally in a regulatory capicity. Medical device regulatory experience desirable. Demonstrated leadership and organizational skills. Understanding of commercial business. Demonstrated ability to handle multiple projects. Working knowledge of local regulations and guidelines related to drug development and registration. Excellent verbal and written communication skills. Work successfully within a team environment and as an individual contributor. Flexible and ability to adapt to changing regulatory environment and business needs. Proficient use of technology including MS office programs and Internet resources.

Responsibilities

Review and assess design and CMC changes, and prepare submissions to ensure compliance with pharmaceutical regulatory requirements. Support regulatory input for quality system deliverables and maintain effective relationships with various stakeholders.