Regulatory Affairs and Pharmacovigilance Senior Specialist [Finland]

 

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

As part of our Company’s Animal Health Nordics cluster and working alongside one other individual, you will be responsible for Finnish regulatory tasks connected to market authorisation, quality of our products and pharmacovigilance. Working with agility, you will have a central role in ensuring the quality, safety and efficacy of all veterinary medicines within our dynamic, market-leading organisation.

Please submit you application before 17th July!

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Your responsibilities will cover:

Regulatory Affairs

• Coordination of all regulatory activities for vaccines and pharmaceuticals for Finland in cooperation with Business operations and Global Regulatory departments
• Timely preparation and submission of new registrations and all other related regulatory submissions e.g. variations, renewals;
• Preparation and revision of country-specific packaging material according to the approved registration within the company labelling software
• Close collaboration with marketing and logistics during the whole product lifecycle and especially during product introduction on the market
• Regulatory review and release of marketing material foreseen for the Finnish market
• Maintenance of regulatory compliance by following our Company Animal Health regulatory affairs policies and procedures and country regulations
• Cooperation with national associations

Pharmacovigilance

• Designated Point of Contact for Pharmacovigilance
• Maintenance of a Pharmacovigilance quality management system
• Reporting and submission of product complaints and pharmacovigilance reports in compliance with our Company's Animal Health policies and national legislation

Deputy Responsible Person (FFA) in Finland

• Deputy Responsible for the GDP Quality Management System, internal roll out and training

Experience

• Working experience in regulatory affairs or adjacent areas from the pharmaceutical, biotech or animal health industry or regulators
• Familiar with both EU and Finnish legislation
• You should have a background as a pharmacist or similar
• Excellent organizational skills and an ability to work to deadlines
• Project management skills
• Meticulous and detail-oriented
• Strong communication and interpersonal skills, able to foster a strong working relationship with both internal and external stakeholders
• Fluency in English and Finnish, both written and spoken and interest in the writing process

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving the health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer 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 digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Regular

Relocation:

Domestic

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R246686

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