Work Location: Billerica, Massachusetts
Shift:
Department: HC-RD-RCD1 Reg CMC LM Marketed 1
Recruiter: Sarah Ellis
This information is for internals only. Please do not share outside of the organization.Your Role:The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document as well as all CMC Dossier types, their content and decision making on content, for assigned submissions worldwide, and serves as the Regulatory Affairs CMC contact point and acts as the liaison with the GHO and R&D functions, being the contact person for all Regulatory CMC topics.
Location: Hybrid (3x/week) in Billerica, MA office
Key Accountabilities:Global Product Oversight:
- Ensures global product oversight for the regulatory CMC part of the product / project
Regulatory CMC strategy and Health Authority interactions:
- Develops, defines and is accountable for the Global Regulatory CMC strategy for development and Life Cycle Management programs. Leads and drives global regulatory CMC strategy for the assigned projects/products in target regions/countries. This encompasses responsibility for the Regulatory CMC topics, risk assessment & mitigation, regulatory CMC strategic support and advice to interdisciplinary internal teams
- Leads HA meetings and represents GRA in Health Authority interactions on CMC topics
Management of CMC Regulatory Activities; CMC Dossier generation:
- Responsible and accountable for driving all regulatory CMC activities for assigned projects/products. Develops, authors and owns the CMC dossier Strategy Document as well as all CMC Dossier types; being accountable for CMC Dossier content and content decision of all CMC Dossier types such as IMPD/IND, BB (incl. meeting request), variations, amendments, renewals, Module 1 CMC regulatory binding documents, Annual reports, IB CMC, ATOs up to approval.
- Provides the Global Regulatory CMC advice & expertise in cross-functional project teams.
- Acts as liaison between Global Health Operations and R&D functions as single point of contact for all CMC topics.
- Accountable and responsible to provide country specific regulatory CMC requirements for CMC dossier strategies and plans.
- Regulatory CMC assessment of in-and out licensing projects for business development (Due Diligence).
Regulatory intelligence and knowledge management:
- Is the expert for CMC regulations, guidance, regulatory trends and competitive environment, incl. accelerated pathways, CMC innovations
- Reviews draft and newly released laws and guidance on behalf of the Company. If required, being a member in trade associations. Leading and participation in internal as well as cross-functional, international initiatives.
Global Regulatory Affairs CMC coordination:
- Support development and execute initiatives
- Plans regulatory CMC activities and develops submission roll-out plans, in close collaboration with key stakeholders
Who You Are:Minimum Qualifications:- Degree in a Life Science or related discipline (e.g. MSc or equivalent degree, PhD in a scientific discipline is preferred)
- 7+ years of pharmaceutical industry experience, with global regulatory CMC experience
Preferred Qualifications:- Ability to develop and prepare successful regulatory CMC strategies and CMC dossiers
- Experience in preparation and management of regulatory CMC documentation, a full international submission (new product application) or large variations
- Experience with life-cycle management activities in EU, USA and International
- US regulation expertise
- Practical experience in one of the following area: manufacturing process development, transfers, validation or analytical development and control strategies
- In-depth knowledge of global pharmaceutical legislation
Pay Range for this position: $134,200 - 202,200
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prerequisites. For more information click here.
