Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
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Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Taguig, National Capital Region (Manila), Philippines
Job Description:
Position Summary
The Senior Regulatory Affairs Specialist is a member of the local Regulatory Affairs department, responsible for actively contributing to the regulatory compliance of medical devices products under their responsibility. The position is responsible for providing input into the global regulatory strategy and identifying country requirements for successful regulatory filings for new products/indications and line extensions.
Key Responsibilities
The Senior Regulatory Affairs Specialist will be a member of the local Regulatory Affairs department within Johnson & Johnson MedTech, with responsibility for regulatory aspects of the assigned product portfolio/s or Projects.
Preparation of submissions to the local health authority for new products and variations to existing products in line with Marketing launch plans.
Maintain departmental and source company databases of regulatory approvals.
Labelling and promotional material review as required.
Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in local market and request the documentation required for registration submissions.
Build constructive relationships with the local health authority by compiling and submitting required documents and providing prompt responses to questions.
Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio.
Participate in discussion groups for the industry association or discussion with HA, as required.
Contribute to continuous review and improvement of processes within the Regulatory Affairs department to ensure consistent, efficient and effective practices across the team.
Contribute to Regulatory Affairs Team meetings to learn from colleagues, share experiences and best practice.
Coordinate the release for supply of unapproved medical devices under the Special Access Scheme (SAS)/ Special Access Importation.
Engage marketing to strategize new product regulatory pathways, line extensions and changes to currently approved products and actively accelerate launch timelines.
Manage interactions with stakeholders and distribution centers as required to ensure product supply is not disrupted.
Support internal and external audits.
Required Qualification and Core Competencies
A bachelor’s degree in pharmacy, with an active pharmacist license registered in the Philippines.
Familiarity with the medical device regulatory systems and product registration requirements in the Market;
Have practical experience with the market health authority, preferably the medical device health authority;
Strong attention to detail and a methodical approach to data handling and documentation.
Strong analytical and comprehension skills.
Excellent verbal and written communication skills; proficiency in English is required.
Able to work effectively in a matrixed, fast-paced environment.
Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment;
Proactive team player, able to take charge and follow-through.
Eager to learn, collaborative team player, and self-motivated.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork