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Regulatory Affairs Specialist III
Ref No.: 18-09299
Location: Cambridge, Massachusetts
Major Activities/Key Responsibilities
Responsibilities include:
Global Regulatory Team Lead for 30 INNs within the Established Products Group.
Develop the Global Regulatory Product Strategy (GRPS).
Interface with the development/project teams.
Represent the GRT at Regulatory Sr. Management Committees and other governance reviews.
Attend Health Authority (HA) meetings as required.
Lead and stimulate the Global Regulatory Team.
Develop the competitive target label and Company Core Data Sheet.
Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
Liaise with HA contact person; organizing and preparing HA meeting and leading.
Accountable for keeping the databases updated on a timely basis for portfolio.
Provide support and communicating information on products to other functions (approvals, ...).
Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies..
Manage post-submission activities (shortages, DHPC, B/R reevaluation, ...).
Maintain professional working relationships with colleagues, fostering collaboration and idea sharing.
Advise management and team members of major regulatory issues and actively contribute to their management.

Experience/Professional Requirement:
Strong strategic skills including the ability to make complex decisions
Excellent operational skills including planning, organizing and ability to motivate and lead others.
Strong sensitivity for a multicultural/multinational environment
Knowledge about the Global Business Unit organizational structure, how business is driven (with financial understanding)
Knowledge about the discovery and development of pharmaceutical products, the role and importance of the RA function and how it fits into the development process
Knowledge about the Global regulatory environment including specialized Therapeutic areas as appropriate, the organizations involved and how legislation is developed
Experience with the current procedures for obtaining approval to carry out clinical trials at Global level (e.g. IND, CTAs, IMPDs and other supporting documentation) as well as on how best interact with regulatory bodies and HTAs for optimizing development strategy
Experience with registration procedures in major markets for MA approvals, variations, extensions and renewals and the importance of regulatory strategy to obtain the best possible outcome
Experience with the content and format of registration files (Common Technical Document and eCTD) as well as on how to best interact with regulatory bodies during the review processes