Senior Associate Global Regulatory Affairs CMC Biologics
Location: Westborough, MA
Job Category: Research & Development
Brief Description: This position is responsible for providing regulatory Chemistry, Manufacturing and Controls (CMC) for licensed and clinical biological products.
Senior Associate Global Regulatory Affairs CMC Biologics Key Responsibilities:
1.Coordinate and prepare document dossiers for regulatory submissions, ensuring compliance with required regulations and interpretations.
2.Provide project team representation and act as liaison to obtain information from other departments regarding regulatory submissions or documentation.
3.Review technical documentation and recommend changes for regulatory compliance ensuring conformances with existing regulatory approvals.
4.Research and analyze regulatory information.
5.Maintain current regulatory knowledge and keep abreast of regulatory procedures and changes.
6.Support all aspects of assigned ad-hoc or planned regulatory projects with internal teams or affiliates.
7.Contributes to the completion of milestones associated with specific projects. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules, and may result in the allocation of additional resources.
Senior Associate Global Regulatory Affairs CMC Biologics Basic Qualifications:
1.Bachelor's degree and at least 3 years of Regulatory Affairs or relevant industry experience
2.Master's degree and at least 1 year of Regulatory Affairs or relevant industry experience
3.Experience with biological products.
4.Excellent organizational and communication (written and verbal) skills.
5.Demonstrated ability to work successfully on project teams.
6.Previous experience working in a fast paced environment on multiple product lines
7.Manufacturing, QA/QC experience
8.Ability to effectively interpret guidance and provide recommendation to key stakeholders
Senior Associate Global Regulatory Affairs CMC Biologics List of Major Activities:
1.New applications for drugs/biologics
2.Plan/Prep/Submit/Review support for product dossiers
3.CTA / IND preparation and maintenance
5.Recurrent filings: annual reports (US, Canadian NDC and YBPR, license and renewals)
6.Site renewals (ex. Japan Accreditation)
7.Post Approval Supplements
8.Regulatory strategy development
9.Preparing / Authoring / Review of Submissions - US, EU and Rest of World (ROW)
10.Technical Review of site supporting documents (CoA, declarations, SMF, MBR, SOPs)
11.Notify Reg Ops for publishing and dispatch to BoH
12.BoH Response to Queries - US, EU and ROW
13.liaise with EMA and EU member state BoH on CMC topics
14.Post Approval Supplements
15.Regulatory strategy development
16.Preparing / Authoring / Review of Submissions - US, EU and Rest of World (ROW)
17.Technical Review of site supporting documents (CoA, declarations, SMF, MBR, SOPs)
18.Notify Reg Ops for publishing and dispatch to BoH
19.BoH Response to Queries - US, EU and ROW
20.Change Controls & Change control assessments
21.Initiate change in regulatory database and follow-up with local regulatory representatives on the assessments of the change.
22.Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations.
COMPENSATION & CANDIDATE DETAILS
1.Competitive Base Salary
3.Security Clearance Not Required
4.Visa Candidates Not Considered
5.Relocation Assistance Not Available
7.Not Overtime Eligible
8.Interview Travel Not Reimbursed
9.2+ to 5 years experience
10.Management Experience Not Required
11.Minimum Education - Bachelor's Degree
12.Willingness to Travel Occasionally