Our Clare based multinational pharma client has an immediate opportunity for an experienced Regulatory Affairs Specialist to join their team on contract – 12 to 15 months.
The Reg Affairs Specialist's responsibilities include the development, and maintenance of regulatory submissions, documentation, annual reporting etc as required.
Responsibilities
•Manage all regulatory affairs activities to support product development through all stages of the development cycle, including preclinical, and marketing issues
?understanding of regulatory requirements throughout the global marketplace companies pharma products
?Maintain regulatory filings and compile all documentation needed for annual reporting and approval supplements
?Support department members and senior management by proactively seeking opportunities to improve company functioning, assisting team members, and accepting additional assignments positively
?Analysing risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities
?Managing the preparation of registration packages and responses to deficiency letters
?Negotiating submission data requirements and deliverable dates with regulatory authorities and internal technical teams
?Author with team members, key pieces of regulatory submissions
?Acting as a point person for regulatory agency interactions (either written or oral), including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams
?Evaluating manufacturing and labeling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations
?Maintaining awareness of global regulatory legislation and assess its impact on business and product development programs
?Responsible for all worldwide regulatory submissions including FDA etc. and all amendments, etc. for all regulatory bodies.
?Supports the ongoing compliance by identifying and correcting gaps in procedures as required and designing and presenting training programs to educate employees
?Ensure ISO13485 compliance
?Ensure compliance with the various worldwide standards as per business requirements
?Coordinate product registration process in foreign countries
?Leads Corrective and Preventive Action (CAPA) activities and uses Root Causes Analysis tools to document CAPA activities. Responsible for reviewing, documenting, logging, maintaining and/or initiating the investigation for potentially serious complaints.
?Supports AMD product development process, document and implement regulatory strategies, including registration requirements, needed to help facilitate timely launch of new products.
•Support planning, preparation, and submission of regulatory pharma submissions.
•Provide strategic regulatory insight to team members regarding product development plans
•Manage interactions with FDA and other regulatory authorities
•Monitor global regulatory trends and requirements impacting the development and commercialization of products, and advise colleagues and external partners to ensure ongoing compliance
Desired Skills and Experience:
•Science Degree ideally in Chemistry
•Minimum of 4 years experience in regulatory affairs for a pharmaceutical, biotech, or medical device company. .
•Regulatory Affairs Certification (RAC) is desirable.
•Thorough understanding of FDA Quality System regulation, ISO 13485,
•Thorough understanding of international regulatory requirements for pharma
•Proven track record in writing major regulatory submissions, with the ability to successfully manage projects to deadlines
•Previous domestic/international submissions experience.
•Experience of clinical trials a plus
•Strong ability to manage critical projects as part of an interdisciplinary team
•Excellent problem solving and communication skills
•Must be self motivated and detailed oriented
•Experience working directly with regulatory agencies
•Excellent oral and written communication skills
eFlexes is an equal opportunities employer
