Sr Mgr Global Regulatory CMC & Devices-Small Molecule Mrked
Location: Bridgewater, NJ
Job Category: Research & Development
The candidate is responsible for strategic leadership within the Global Regulatory CMC & Devices Group, Small Molecule Marketed.
Candidate is responsible for the US & global regulatory CMC for a range of marketed products ("small molecules") approved by the FDA, European Medicines Agency (EMA) Centralized Procedure (CP), De-Centralized Procedure (DCP) and Mutual Recognition Procedure (MRP) as well as other National Health Authorities.
The scope of activities involves:
1.Maintenance of marketed products as needed
2.Regional/Pharmaceutical Operations/Industrial Affairs sponsored non-R&D life-cycle management projects
3.Territory extensions and licensing activities for chemical entities
4.Responsibilities include preparation of regulatory strategies for NDA /510(k), MAA, NDS, DMF/ASMF Supplements, Variations, and Annual Reports/Renewals.
5.These activities include performing as a Global Leader and US Contact (located in US/EU) to develop regulatory CMC strategies for changes at our industrial sites or Health Authority requirements.
6.Non-R&D LCM Projects would normally involve development activities in addition to maintenance activities for which pre- and post-approval regulatory CMC strategies would be required. Therefore, the incumbent should have expertise in development as well as maintenance regulatory requirements. Full development and post-approval knowledge is considered critical to the success of the project.
7.For US- and EU-approved products (MRP, CP, DCP), the incumbent is additionally responsible to facilitate completion of submission dossiers through GRA Operations, assure that submission dossiers comply with the regulatory CMC strategies, author and sign (as appropriate) submission dossier application forms and communications and directly interact as liaison with any Health Authority contact (telephone, face-to-face, etc.).
Required Knowledge and Skills:
1.Experience in working in a team environment within a large organization
2.Good knowledge of pharmaceutical product development and relevant health Authority regulations is essential to support registration of marketed products and life-cycle management
3.Must have some knowledge of Key Health Authority thinking, anticipatory foresight and be able to assume leadership and management of projects.
4.Should demonstrate a high level of initiative
5.Be able to communicate effectively to broad sophisticated audience both internally and externally
6.Be comfortable in the use of databases and tools (Regulatory databases, Excel, Powerpoint, etc.)
1.Formal Education and Experience: BA/BS in a science/health field (i.e., Chemistry, Pharmacy, Biology) plus 7 years industrial experience (chemical, analytical, pharmaceutical, manufacturing) including 4 years in regulatory CMC or advanced degree (MS/MA, PhD) in a science/health field plus 4 years industrial experience including 2 years in regulatory CMC.
2.Security Clearance Not Required
3.Visa Candidate Not Considered
4.Competitive Base Salary
6.Relocation Assistance Not Available
8.Not Overtime Eligible
9.Interview Travel Not Reimbursed
10.5+ to 7 years experience
11.Management Experience Not Required
12.Minimum Education: Bachelor's Degree
13.Willingness to Travel Occasionally
14.IDEAL CANDIDATE MUST HAVE: CMC and regulatory affairs experience