Senior Manager Global Regulatory Affairs CMC
Location: Westborough, Massachusetts (near intersection of 495 & 90)
Industry: Pharmaceutical / Biotech
Job Category: Research & Development
This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls (CMC) for licensed and clinical biologic products. Candidate will assist with the product strategy and the direction provided to commercial and clinical teams. The Candidate will also assure the established regulatory strategy is aligned with Global Health Authority requirements and be responsible that regulatory submissions are on time and of high quality.
Other responsibilities include:
1.Coordination with our global manufacturing sites, integration of regulatory strategy across those sites and communication to senior management.
2.Mentoring, supervision and coaching a team of regulatory professionals.
3.Supporting other CMC projects as needed.
4.Experience working in a matrix environment using excellent people skills is required.
Senior Manager Global Regulatory Affairs CMC Key Responsibilities & Activities:
1.New applications for 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.Interaction / 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
21.Change control assessments
22.Initiate change in regulatory database and follow-up with local regulatory representatives on the assessments of the change.
23.Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations.
Senior Manager Global Regulatory Affairs CMC Basic Qualifications:
1.University degree in scientific discipline with 3-5 years regulatory experience.
2.Knowledge of FDA regulations is essential.
3.Experience with biological products
Senior Manager Global Regulatory Affairs CMC Preferred Skills:
1.Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
2.Excellent organizational and communication (written and verbal) skills.
3.Demonstrated ability to work successfully on project teams.
4.RAC certification preferred.
5.Previous experience working in a fast paced environment on multiple product lines
6.Manufacturing, QA/QC experience
7.Security Clearance Not Required
8.Visa Candidates Not Considered
Compensation & Candidate Details
1.Base Salary is Competitive
3.Relocation Assistance Not Available
4.No Commission Compensation
6.Not Overtime Eligible
7.Interview Travel Not Reimbursed
8.5+ to 7 Years of Pharma Regulatory Affairs Experience
9.Management Experience Not Required
10.Minimum Education - Bachelor's Degree
11.Willingness to Travel - Occasionally
Senior Manager Global Regulatory Affairs CMC Screening Questions
1.Does candidate have 3-5 years regulatory experience?
2.Does candidate have Biologics experience?