The position is related to veterinary medicinal products/Animal Health Business.
The Local Regulatory Affairs, Pharmacovigilance and Quality Assurance Specialist provides support, control and communication around veterinary medicinal products marketing authorizations (MA) and is responsible for Regulatory Affairs, Pharmacovigilance, Clinical Trials and Quality Assurance topics and processes, acts in a business-oriented way in terms of Regulatory Affairs during product development, as well as to get the best-authorized profile in order to introduce the product in the market in the shortest period.
In the field of pharmacovigilance is supporting all pharmacovigilance (PV) activities for our company’s products. This includes management of the day-to-day adverse events as well as the development/update/implementation/training on standard operational procedures (SOP).
In addition, supports SOP on market support studies as well as the approval process of marketing and sales activities.
Job Description and Responsibilities
New Marketing authorizations
Ensures timely and correct submission and approval of new MA applications in close cooperation with relevant persons namely Local Regulatory Affairs Specialist/Manager and in global regulatory affairs, management, marketing, external affairs departments, research, our Manufacturing Division on local or global level.
Tracks process and manages answers to requirements from the Agency on products registration and major new indications, involving negotiations to achieve the best commercial outcome.
Actively supports translation of product literature to local language.
Manages packing material requests, development and approval.
Assisting in organization and overseeing field trials for new products.
Maintenance of Marketing Authorization (MA)
Ensures that MA are maintained through control of due time frames and a timely implementation of necessary activities including variations (and renewals, if required).
Communicate actions and evolution to stakeholders using the described process if such exists.
Manages packing material updates requests, development and approval.
Assisting in organization and overseeing field trials for new indications.
Compliance and Artwork
Supports maintenance and update of the databank of valid versions of Summary of Product Characteristics (SPC), packaging materials and other applicable regulatory documents according to our Company and local standards.
In coordination with Local Regulatory Affairs Specialist/Manager inform internal stakeholders and colleagues on all relevant information with regard to the regulatory status of the products namely on update of SPC, via a regular RA communication on update on the status of main activities and main RA topics to share.
Stay in contact with our Manufacturing Division to ensure that updated artworks of product packaging are produced and used within legal timeframes, namely by appropriate use software to generate artwork and to implement revisions of the artwork in due time.
Guarantees consistent use of internal and external regulatory databases and systems in the country in such a way the data provided are the most up-to-dated.
Keep files and archives related to Regulatory Affairs complete and updated.
Establishes and updates the relevant Standard Operating Procedures (SOP) to secure the current internal and external requirements on Regulatory Affair of the organization are compliant and implemented in requested time-lines.
Provides regulatory representation and support for internal and external audits related to regulatory affairs field.
Cross-functional activities
Ensures adequate support to other functions to enable compliance in areas related to regulatory, such as review of promotional material, customer presentations incl. social media.
Gives strategic regulatory advice or feedback to maximize best positioning of products and company business.
Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners if relevant.
Takes part in BU products and launch teams to provide regulatory input and strategy advice is such is requested.
Support such the decisions they provide the best return on their commercial implications and is aware about the cost created by Regulatory Affairs.
Good Distribution Practice
May be required to act as Qualified Person/Responsible Person for Veterinary Wholesale (in area of the Good Distribution Practice) or directly support/cooperate with this role
Regulatory Affairs environment
Keeps abreast of local (in the country of operation) and EU and international laws and tendencies in order to identify and track on topics they might influence our company’s interests.
Through active participation in the regulatory work of the local Pharmaceutical industry Association and task forces with the Agency, the incumbent seeks alignment of industry position with our company’s interests if required.
Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders, and in concurrence with our company’s Regulatory Affairs positions.
Participates in internal RA managers’ meetings and contributes to our company’s workgroups or projects if so required.
Acts as a contact point for quality issues for Local Regulatory bodies.
Provides translation of the product literature from and to English language if requested.
Maintains PV system, which ensures that information about all adverse events (AEs) that are reported to any personnel of our company, including its representatives, temporary staff and contract employees, is collected and collated in order to be accessible in at least one point within the EEA.
Oversees of the pharmacovigilance data quality and information collection process.
Enters reports to pharmacovigilance database (translated to English language) and processing related data and documents in accordance to actual requirements.
Develops and adapts applicable local procedures including training of personnel, documentation of the training process and process implementation.
Assures the implementation of appropriate Pharmacovigilance related vocabulary in applicable contractual agreements (including field trials related documentation).
Participates in audits and controls of the PV system performed by competent authorities as well as involvement in post-audit and post-control activities.
Conducts continuous overall PV evaluation during the post-authorization period.
Ensures that any request from the national competent authorities (NCAs) for the provision of additional information necessary for the evaluation of the benefits and risks of a VMP is answered fully and promptly, including the provision of information about the volumes of sales or prescription of the VMP concerned (in accordance to corresponding procedures).
Provides to the NCAs of any other information relevant to the evaluation of the benefits and risks of a VMP, including appropriate information on post-authorization studies (in accordance with corresponding procedures).
Ensures close coordination and communication with Country Manager, Global Qualified Person responsible for Pharmacovigilance (QPPV) or Global PV team, Regulatory Manager of any other member of local DPOC team if assigned despite the position is responsible for independently carrying out these and other tasks.
Review marketing and sales promotional material on scientific content to ensure scientific accuracy and compliance with local regulations
Ensures that all activities are in line with compliance and our company’s code of conduct.
Percentage of travel:
Up to 20%
Alternative location/sites:
Hybrid/Office/Flexible/Home Office
Education: Veterinary Medicine (graduated Veterinarian) MUST HAVE
Skills Required:
Proficient in native language due to daily work with native language materials
Excellent in English, written and verbal, skill is needed to prepare translation of the English texts to national language
Preferred at least 1-year experience in regulatory affairs
Preferred experience in pharmacovigilance
Preferred experience in Good Distribution Practice and Quality Assurance
Familiar with local and EU legislation procedures at the level of regulatory affairs
Excellent communication skills
Excellent teamwork
High level of diplomacy
Excellent planning and organization skills
Open for changes
Competent use of MS Office
Flexibility in working hours i.e. being available for emergencies by either mobile phone, office or home telephone, email or fax outside of office hours.
Professional Competencies
Project Management- Applying
Productive Communication – Applying
Problem Solving – Applying
Core Commercial Competencies:
Customer engagement – Applying
Product knowledge and portfolio management – Applying
Regulatory and compliance knowledge – Applying
PV Intelligence
Knowledge of pharmacovigilance systems & requirements – Applying
Knowledge of local country(ies) industry code(s) of practice – Applying
Knowledge of pharmacovigilance principles, concepts, practices & standards – Applying
In depth knowledge of the local country(ies) pharmacovigilance regulations & obligations – Applying
Other competencies:
Local country language – native speaker
Czech language – Advanced
About our Company Animal Health
At our Company, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines, and innovative health solutions for the world’s most challenging diseases.
Our Animal Health division is the global animal health business of our Company. The company’s innovative portfolio includes technology, products and solutions to help, improve or enhance animal management and health outcomes across Livestock and Companion Animal species. Through its commitment to The Science of Healthier Animals®, our Company Animal Health offers veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products.
Our Animal Health has a rich history of innovation, commitment to research and entrepreneurship in animal health dating back over 70 years. The company is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. Healthier animals mean a sustainable food supply, protection for humans against diseases passed from animals, and longer, healthier lives for pets. It invests extensively in dynamic and comprehensive R&D and technological resources and a modern, global supply chain. The company is present in more than 50 countries, while its products are available in some 150 markets.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Valid Driving License:
Hazardous Material(s):

Requisition ID:R225882

Leave your comment

Your email address will not be published. Required fields are marked *