Regulatory Affairs consultantPSC Biotech

Job Description:
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.
We focus on providing quality consulting services to ensure our client's success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer's expectations.
We are hiring a Regulatory Affairs Consultant. This is a remote position. The Regulatory Affairs Consultant will combine different skillsets and responsibilities. The ideal candidate will be performing hands-on Regulatory Affairs consulting activities and support internal operations
Responsibilities
Provide guidance on regulatory documents and submissions, ensure compliance with workplace safety or hazardous material rules, etc.
Develop regulatory strategies/plans
Provide proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans.
Identify and assess regulatory risks associated with product development for assigned projects.
Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel as appropriate.
Providing regulatory advice regarding pre-and post-marketing regulatory activities to a variety of clients.
Preparation and submission of applications for marketing authorizations and variations including response to deficiency letters.
Ensure efficient and effective communication with regulatory authorities.
Review and maintain project documentation and records.
Participate in Risk-Benefit Analysis for regulatory compliance.
Review, revise, and author regulatory documentation.
Additional duties and responsibilities may be assigned from time to time.
Requirements
Bachelor's Degree in related field of study.
3-5 years of experience in Regulatory Affairs within the life science industry.
Strong knowledge of FDA submissions and guidelines.
Proven ability to work successfully with cross-functional teams and influence appropriate plans and actions.
Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
Excellent interpersonal, communication, analytical, managerial, and organizational skills.
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PSC Biotech

Makati City, Metro Manila
Permanent
Full-time