Collabera
Regulatory Affairs Leader (Associate Director)
Collabera, Marlborough, Massachusetts, us, 01752
Regulatory Affairs Leader (Associate Director)
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services.Role Summary/Purpose:The Regulatory Affairs Leader - Pharma may be involved in Pre or Postmarket duties or both.Provides subject matter expertise and works with a team of RA professionals to ensure best practices in premarket & postmarket for RA.Ensures accurate & optimal submission of regulatory medical product clearance files & postmarket reports that meet the requirements of the region or country.File / Maintain regulatory deliverables.Analyze & communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies.Support local regulatory authority / notified body inspections as required.Educate, train, & advise company professionals to ensure compliance with regulatory requirements.Coach and mentor other RA professionals.Premarket Responsibilities:Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country Regulatory market clearance submissions.Communicate with Product RA resources to establish regulatory requirements, including clinical trial data.Provide RA support as needed to clinical studies to ensure regulatory requirements are met.Partner with Product RA professionals to review advertising and promotion materials for compliance.Act as liaison with external regulatory reviewers to gain rapid approval of submissions.Work with appropriate Product RA representative for countries with license expiration requirements.Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions.Postmarket Responsibilities:Reviews new reportable adverse events for country reportability.Prepare Recall submissions, localize if applicable.Prepare Regulatory Authority responses to inquiries.Following PSRB decision, review field action information to determine if reportable in local country.Support regulatory compliance and optimization of quality system procedures relating to post market reporting.Act as liaison with external regulatory bodies as required.Provide evidence of official closure of postmarket actions (e.g. AERs and Recalls) to the P&L.Monitor external information for incidents or issues that may involve product.Quality Specific Goals:Aware of and comply with the Quality Manual, Quality Management System, and applicable laws and regulations.Complete all planned Quality & Compliance training within the defined deadlines.Identify and report any quality or compliance concerns and take immediate corrective action as required.Maintain up-to-date knowledge and understanding of current regulatory requirements.Ensure assigned regulatory submissions are accurate, complete and timely.Qualifications/Requirements:Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the pharmaceutical or biotechnology industry or with regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience.Ability to prioritize, plan & evaluate deliverables to established strategic goals.Proven application of analytical skills in a regulatory environment.Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.Strong problem solving and negotiation skills.Ability to work well independently & in a team setting.Prior experience using spreadsheet and presentation software.Must be willing to travel up to 10% of time.Desired Characteristics:IND, NDA or related submission experience.Regulatory Affairs Certification (RAPS).Demonstrated experience interfacing with regulatory agencies.Knowledge of Quality Management Systems (QMS).Experience with working across cultures/countries/sites.Demonstrated experience prioritizing conflicting demands.Demonstrated understanding of healthcare environment and knowledge of current competitive situations.Experience with adverse event reporting and recalls.If you are interested and want to apply, please contact:
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Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services.Role Summary/Purpose:The Regulatory Affairs Leader - Pharma may be involved in Pre or Postmarket duties or both.Provides subject matter expertise and works with a team of RA professionals to ensure best practices in premarket & postmarket for RA.Ensures accurate & optimal submission of regulatory medical product clearance files & postmarket reports that meet the requirements of the region or country.File / Maintain regulatory deliverables.Analyze & communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies.Support local regulatory authority / notified body inspections as required.Educate, train, & advise company professionals to ensure compliance with regulatory requirements.Coach and mentor other RA professionals.Premarket Responsibilities:Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country Regulatory market clearance submissions.Communicate with Product RA resources to establish regulatory requirements, including clinical trial data.Provide RA support as needed to clinical studies to ensure regulatory requirements are met.Partner with Product RA professionals to review advertising and promotion materials for compliance.Act as liaison with external regulatory reviewers to gain rapid approval of submissions.Work with appropriate Product RA representative for countries with license expiration requirements.Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions.Postmarket Responsibilities:Reviews new reportable adverse events for country reportability.Prepare Recall submissions, localize if applicable.Prepare Regulatory Authority responses to inquiries.Following PSRB decision, review field action information to determine if reportable in local country.Support regulatory compliance and optimization of quality system procedures relating to post market reporting.Act as liaison with external regulatory bodies as required.Provide evidence of official closure of postmarket actions (e.g. AERs and Recalls) to the P&L.Monitor external information for incidents or issues that may involve product.Quality Specific Goals:Aware of and comply with the Quality Manual, Quality Management System, and applicable laws and regulations.Complete all planned Quality & Compliance training within the defined deadlines.Identify and report any quality or compliance concerns and take immediate corrective action as required.Maintain up-to-date knowledge and understanding of current regulatory requirements.Ensure assigned regulatory submissions are accurate, complete and timely.Qualifications/Requirements:Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the pharmaceutical or biotechnology industry or with regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience.Ability to prioritize, plan & evaluate deliverables to established strategic goals.Proven application of analytical skills in a regulatory environment.Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.Strong problem solving and negotiation skills.Ability to work well independently & in a team setting.Prior experience using spreadsheet and presentation software.Must be willing to travel up to 10% of time.Desired Characteristics:IND, NDA or related submission experience.Regulatory Affairs Certification (RAPS).Demonstrated experience interfacing with regulatory agencies.Knowledge of Quality Management Systems (QMS).Experience with working across cultures/countries/sites.Demonstrated experience prioritizing conflicting demands.Demonstrated understanding of healthcare environment and knowledge of current competitive situations.Experience with adverse event reporting and recalls.If you are interested and want to apply, please contact:
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