Senior Manager, Global Regulatory Affairs CMC

Merck•Billerica, MA

22h•Hybrid

About The Position

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. This role 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. The position is hybrid, requiring 3 days per week in the Billerica, MA office.

Requirements

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

Nice To Haves

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

Responsibilities

Ensures global product oversight for the regulatory CMC part of the product / project.
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.
Responsible 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.
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.
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).
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.
Support development and execute initiatives.
Plans regulatory CMC activities and develops submission roll-out plans, in close collaboration with key stakeholders.