Senior Specialist Regulatory Affairs

Basic Functions & Responsibility

• For assigned products, ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to the local authorities and – as applicable – to the EMA.
• Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• For assigned products ensures timely, accurate and compliant labelling translations and artwork preparation.
• For assigned products and tasks, stays updated on late MSD pipeline filings, relevant EU and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.
• Maintains a positive relationship with internal and external regulatory contacts. GRACS on sub-regional, regional, and global level, MMD, EUQPPV and GCS&PV are the main contact points within the company. External contacts are regulatory authorities, as well as other key players in the regulatory environment.

Major Activities

Maintenance of licenses for assigned products

• Performs timely and correct submission and approval of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing and external affairs departments, GRACS on sub-regional, regional and global level, as well as with local regulatory authorities as appropriate, depending on procedure type. Coordinates and implements early access programs with the Agency. Tracks process and manages answers to objections from the Agency on products registration and major new indications, involving negotiations to achieve best conditions.
• Designs and implements local action plans for new products, involving selection and regulatory training of external experts and closely interacting with the Agency and Advisory Committee members, with continuous interface with RAE.

Maintenance of licenses for assigned products

• Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicates approvals to stakeholders through the correct processes.
• For major indications, designs and implements local action plans as above mentioned for new MA applications.

Compliance

• For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians’ circulars, packaging material and other applicable regulatory documents according to MSD and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.

Labelling and artwork

• Ensures high quality translations and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents.
• Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.

Cross-functional activities

• Obtains early information about new studies to be able to advice on Clinical Trial Applications and study planning as appropriate to the local GCTO group responsible for Clinical Trials.
• Ensures adequate support to other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.
• Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners as appropriate.
• Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
• Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.

Regulatory policy & environment

• Keeps abreast of local and international laws, collects relevant publicly available regulatory information, provides insights and responds to consultations on proposed national regulatory guidance, as appropriate, and communicates final regulatory guidance for awareness and impact assessment, in cooperation with Global Regulatory Policy.
• Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization, and other stakeholders, and in concurrence with the EU Regulatory Policy lead.
• Participates in internal regulatory policy managers’ meetings at sub-regional and regional level and related regulatory workgroups on selected issues.
• For new regulations, identifies and tracks changes/trends that might impact MSD business.

Pricing and Reimbursement

• Active participation in local P&R teams for the development of pricing and reimbursement applications, as well as complementary documentation, being focused on Added Therapeutic Value, to support best conditions to allow launching of products, and subsequent annual reviews, as well as avoiding potential restrictions due to new indications.

Requirements

MS degree in pharmacy or other life science or equivalent.

minimum of 2 years’ experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies. The incumbent must be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products.

Strong communication skills.

For seniority, an approx. minimum of 4 years’ experience in a Registration Department, dealing with most aspects of registration and experience in supervising others. A sound appreciation of the interactions and relationships of the dept with other groups internally is expected. Must have client-oriented approach and work according to leadership vision.

Current Employees apply HERE

Current Contingent Workers apply HERE

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Valid Driving License:

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Requisition ID:R146325