Aktuelle Jobs im Zusammenhang mit Specialist Regulatory Affairs - Lucerne - MSD

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Specialist Regulatory Affairs

vor 2 Monaten

Lucerne, Schweiz MSD Vollzeit

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.

For our Swiss subsidiary in Global Human Health based in Lucerne, we are currently looking for you to join us as a Specialist Regulatory Affairs (m/f/d) who will be accountable for new marketing authorizations, variations, renewal applications and maintenance of assigned, authorized products of our Company’s franchise.

THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:

  • You will ensure timely preparation and submission of new local Marketing Authorization applications for assigned products as well as appropriate follow-up with the local authorities

  • You will ensure timely preparation and maintenance including translations of local Product Circular, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to our Company’s and local standards

  • You will participate in subsidiary product and launch teams to provide regulatory input and strategy advice

  • You ensure maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations

  • You will develop and maintain positive relationship with key players in the regulatory environment and work with Business Development to boost business initiatives on local, regional and global level

  • You will ensure efficient and consistent implementation and use of internal and external regulatory databases and systems in Switzerland

  • You will participate in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied

  • You will keep abreast of local and international laws; maintain a scientific knowledge and expertise for our Company’s therapeutic areas

​QUALIFICATIONS:

  • You hold a Degree in a Life Science Discipline or equivalent qualification

  • You have a minimum of 2 years’ experience in a Registration Department including hands-on experience in dealing directly with Swissmedic. Alternatively, experience working within a regulatory agency or other related environment

  • You have hands-on expertise in database application

  • Your German language skills are at a native level and you are fluent in English. Additional French language skills are highly beneficial.

  • You are a strong communicator and stakeholder manager; a diplomat with assertive skills in speaking with internal and external parties

  • You possess very good organizational and planning skills and a proven ability to successfully handle conflicting deadlines

  • You work client- focused and business-orientated and you have a sound appreciation of the interactions and relationships of the department with other internal groups

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

The Switzerland Head Office is based in Lucerne's city center. Located in the heart of the city, employees work collaboratively across many departments including commercial, market access, medical affairs, clinical research, regulatory affairs, and policy & communications. The site also serves as our regional and local headquarters for our company’s Animal Health Division in Switzerland.

THE COMPANY…

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

The Switzerland Head Office of our company’s Swiss Subsidiary is based in Lucerne's city centre. Located in the heart of the city, employees work collaboratively across many departments including commercial, market access, medical affairs, clinical research, regulatory affairs, and policy & communications.

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 for the common good. 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

09/30/2024

*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.


Job Posting End Date:09/30/2024


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:R310902