Job Description

Do you want to help our Company become a highly relevant company in Norway - while unleashing your full potential? Do you dream of a job where you manage your own time, and where your efforts make a tangible difference to the lives of real people? Then you could be our new Regulatory Affairs Specialist for our company’s activities in Norway. Join us on our journey!

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

The Regulatory Affairs Specialist will be a product liaison in the local RA team and will have regulatory responsibility for assigned medicinal products, including products in late part of the pipeline, in cooperation with the EU regional RA office, Nordic RA colleagues and cross-functional local and regional colleagues.

As the Specialist, Regulatory Affairs, your role is to

• Ensure timely preparation, submission and appropriate follow-up of new Marketing Authorization applications at local level in collaboration with Regulatory Affairs Europe (getting products to the market).

• Manage maintenance of authorized products through timely submission of variation applications to the NoMA. Ensure timely preparation, maintenance and high-quality translations of local product information, additional risk minimization materials, preparing artworks and other applicable regulatory documents according to our company’s and local standards (keeping products on the market).

• Stay updated on our company’s late pipeline filings, relevant EU and local regulations and guidelines, and develop and maintain a positive relationship with key regulatory stakeholders. External contacts include regulatory authorities, as well as other key players in the regulatory environment.
• Implement effective relationships with internal stakeholders on local and regional levels and collaborate with colleagues from other departments such as Medical Affairs, Quality, Pharmacovigilance, Logistics, Market Access and Business units.
• Actively participate in local cross-functional project teams/launch excellence teams to provide regulatory input and strategy advice, and secure timely and adequate information and decision-making in compliance with the regulatory framework.

Qualifications and Skills Required:

• Master’s degree in pharmacy or equivalent life science education
• Preferably experience from Regulatory Affairs within the pharmaceutical industry or the government administration
• Familiar with local and EU regulatory procedures and guidelines governing medicinal products
• Proficiency in Norwegian and English
• Strong verbal and written communication skills
• Good organizational and planning abilities. Capability to address several tasks simultaneously combined with the capacity to work effectively in a highly regulated environment with tight schedules.
• Demonstrate diplomacy and negotiating skills in dealing with internal and external parties
• Proficiency in PC applications, including word processing, spreadsheets and database usage

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:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Communication Management, Detail-Oriented, Diplomatic Negotiations, Electronic Common Technical Document (eCTD), Employee Training Programs, Life Science, Management Process, Market Access, Medical Affairs, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacotherapeutics, Pharmacovigilance, Product Approvals, Product Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Frameworks, Regulatory Reporting, Regulatory Strategy Development {+ 2 more}

Preferred Skills:

Job Posting End Date:

07/31/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.