Regulatory Affairs Specialist

Job Description

Basic Functions & Responsibility (may not be limited to):

• For assigned products and under supervision of Country Lead/Senior Specialist Regulatory Affairs ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities and – as applicable – to the EMA.
• For assigned products and under supervision of Country Lead/Senior Specialist Regulatory Affairs ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• For assigned products ensures high quality labelling translation and artwork management.
• Supports the Agency interactions to ensure a seamless submission, assessment, and quick approval of the CTAs, according to the new EU CT Regulation, in cooperation with RAE Liaison, and other internal stakeholders, if applicable.
• For assigned products and tasks, stays updated on relevant EU and local regulations and guidelines.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
• Maintains a positive relationship with internal and external regulatory contacts. GRACS on sub-regional, regional and global level, EUQPPV and GSC&PV are the main contact points within the company. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
• By discretion of Regulatory Affairs Management and due to organization and workload, all listed activities need not to be performed.
• Senior position may take on more advanced and independent responsibilities and act as supervisor regarding selected regulatory activities.

Major Activities (may not be limited to):

New MA applications for assigned products

• Under supervision, performs timely and correct submissions and approvals of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing, external affairs departments, outcomes research, GRACS on sub-regional, regional and global level, as well as with local regulatory authorities as appropriate, depending on procedure type. Tracks process on products registration and major new indications.

Maintenance of licenses for assigned products

• Under supervision, 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 communicate approvals to stakeholders through the correct processes.

Compliance

• For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, packaging material and other applicable regulatory documents according local standards and relevant Artwork Management procedures. Implements Product Information within the correct timeframes for compliance.
• Ensures that all internal customers receive relevant information with regard to the regulatory status of the assigned products.
• Ensures the correct and proper utilization of Artwork Management System to generate mock-up artwork and to implement revisions to artwork.
• Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
• Ensures that files and archives related to Regulatory are kept updated and complete.
• Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.

Labelling and artwork

• In connection with submission of MA applications and post-approval submissions provides translation and QRD check of Summary of Product Characteristics, Patient Package Leaflets and labeling including linguistic check of these documents.
• Ensures Electronic Medicines Compendium submissions, approvals and record keeping.
• The above-mentioned tasks are performed under supervision of Country Lead/Senior Specialist Regulatory Affairs as well as Regulatory Affairs International, Global Labelling, Regulatory Affairs Europe.

Artwork

• Prepares artwork, including package leaflets and all other components in a timely and correct manner and according to relevant Artwork Management procedures.
• The incumbent ensures proof reading of packaging components and is responsible for maintaining an updated file on packaging components, as applicable.

Cross-functional activities, as assigned

• 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.
• Adequately supports other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.

Regulatory policy & environment

• Keeps abreast of local and international laws.
• Through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with company interests.
• 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 European regulatory workgroups on selected issues.

Requirements:

Quality

• Ensures support to local Quality Responsible Person in handling of customer complaints and product recalls activities according to standards and local procedures. Closely cooperates with Quality Responsible Person (QRP) / Quality Contact Person (QCP), Customer Service and/or PhV, QP at wholesaler/distributor/importer level and/or Management (Crisis) team.
• Under supervision by QRP/QCP performs assigned tasks regarding product quality and safety according to local requirements.

Qualifications, Skills & Experience

• Must be at least B.Sc. in pharmacy or other life science or equivalent.
• An approx. minimum of 2 years' experience in the pharmaceutical Industry is preferable, in a regulatory, medical or laboratory position.
• Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.
• The incumbent should possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work.
• Must be able to work both alone and as part of a team and have the ability to concentrate on large volumes of written/paper-based work in an office environment.
• The incumbent must demonstrate proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet.
• For seniority, an approx. minimum of 2 years' experience in a Registration Department, dealing with most aspects of registration, with sufficient working knowledge of the subject area to require minimal supervision from the Manager.
• A sound appreciation of the interactions and relationships of the dept with other groups internally is expected.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R313947