Regulatory Affairs Specialist

Job Description

Do you want to help our Company become a highly relevant company in Finland and open doors to exciting international career opportunities for yourself? 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? If so, you could be our new Senior Regulatory Affairs Specialist for our company’s activities in Finland. 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 external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help providing new, reliable, and compliant medical products, practices and solutions to the world.

As the Senior 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.
• Manage maintenance of authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• Ensure timely, accurate and compliant labelling translations and artwork preparation.
• Stay updated on our company’s late pipeline filings, relevant EU and local regulations and guidelines, and develop and maintain positive relationship with key regulatory stakeholders.
• Work alongside the business units locally to support business initiatives and projects in Finland.
• Maintain positive relationship with internal and external regulatory contacts on sub-regional and regional levels and collaborate with colleagues from other departments such as Medical Affairs, Quality, Pharmacovigilance, Logistics, Market Access, Policy and Business units. External contacts include regulatory authorities, as well as other key players in the regulatory environment.

Major Activities:

• Support preparation, submission and approval of assigned new Marketing Authorization applications in close cooperation with Regulatory Affairs Europe, Medical Affairs, Quality, Market Access, Policy and Business units, as well as with local regulatory authorities as appropriate.
• Ensures that marketing authorizations are maintained in compliance through performing the necessary activities, including variations and renewals, within the agreed timeframes and communicates approvals to stakeholders.
• Ensures timely preparation, maintenance and high-quality translations of local Summary of Product Characteristics, Package Leaflets, additional risk minimization materials, preparing artworks and other applicable regulatory documents according to our company’s and local standards.
• Implement Prescribing Information within the correct timeframes.
• Ensures that all internal stakeholders receive relevant information regarding the regulatory status of the assigned products.
• Ensures efficient implementation and use of internal and external regulatory databases and systems.
• Obtain early information about new studies to be able to support local Clinical Trial Applications as well as negotiate with local regulatory authorities as appropriate.
• Ensures adequate support to other functions to enable compliance in areas related to regulatory and secures timely and adequate information and decision-making about regulatory issues in cross-functional teams.
• Take part in product and launch teams to provide regulatory input and strategy advice.
• Shape the regulatory environment by liaising with the local agency, local pharmaceutical organization and other stakeholders, in concurrence with the EU Regulatory Policy.

Skills Required:

• Master’s degree in pharmacy or a related life science field
• A minimum of 4 years’ experience in regulatory affairs, including direct interactions with regulatory agencies.
• Proficiency in Finnish, Swedish, and English
• Strong verbal and written communication skills
• Exceptional organizational and planning abilities
• Meticulous attention to detail
• Ability to handle conflicting time pressures and a high volume of work
• Ability to demonstrate diplomacy and assertive skills in dealing with internal and external parties
• Proficiency in PC applications, including word processing, spreadsheets, database usage, and internet

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

• 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.
  

Requisition ID:R324517