Junior Regulatory Affairs Manager
Vor 7 Tagen
**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**
**Junior Regulatory Affairs Manager (M/F/d)**
Bayer Consumer Health
At Bayer Consumer Health, we believe everyone deserves to live a better life. We believe the key to living a better life is giving people the power to transform their everyday health. This is our mission. This is our challenge. This is what drives every decision we make, every product we develop and every conversation we lead.
**Role purpose**:
The primary objective of the Regulatory Affairs team is to be a business enabler, driving competitive advantage in the marketplace, delivering consumer loved products and services to our customers in a compliant and innovative manner.
The RA organization works as ONE TEAM within Consumer Health (CH) RMSC (Regulatory, Medical, Safety & Compliance) to drive approvals, differentiated claims, as well as competitive strategies to market. It also works externally, monitoring regulations and guidelines and providing CH’s viewpoint in ongoing conversations with the Health Authorities and trade associations.
Our Regulatory country team provides Regulatory input to our internal stakeholders to develop the mid-to-long term strategy of the Swiss CH business, advises on emerging regulatory policy topics, influences the regulatory landscape and develops and executes strategies to enable best route to market as well as to maintain the entire CH country portfolio.
**Your tasks and responsibilities**:
Bayer Consumer Health RMSC (Regulatory, Medical, Safety & Compliance) is looking for a Junior Regulatory Affairs Manager (JRAM) Switzerland to join the country team, which develops & executes regulatory go-to-market as well as life-cycle-management (LCM) strategies and influences the regulatory landscape as part of the Swiss Consumer Health business.
During the normal course of day-to-day duties, the JRAM collaborates with all local country functions, global RMSC, global supply and external stakeholders such as respective Health Authorities to manage the assigned portfolio from new launches to LCM and to ensure compliance.
The JRAM is responsible for the regulatory management of the assigned portfolio (may cover medicinal products, medical devices, cosmetics and food supplements) to ensure consumer centricity, innovation, regulatory excellence & governance and is responsible for:
- Full regulatory management of assigned portfolio under supervision of the Head RA Switzerland, including marketability assessment, marketing authorization procedures and life-cycle management.
- Preparation and implementation of artworks & labels acc to relevant ordinances incl management of internal systems
- Providing support and advice to local business and regional / global functions on the regulatory strategy and processes as well as issues and risks.
In doing so, he/she carries out the following (amongst others):
- Development and execution of regulatory strategies for assigned portfolio under the supervision of the Head RA Switzerland including (but not limited to) go to market routes, label development, change requests, Health Authority requests and marketing authorizations.
- Drafting, change management and implementation of SmPC, PIL and all product relevant artworks acc to local and global regulations including respective systems
- Supporting the Head RA Switzerland on development and maintenance of local work instructions/guidelines/standard operating procedures relevant for local team
- Ensuring compliance with all relevant codes of practice
**Who are you**:
- 12-month experience within Regulatory Affairs, preferably within Switzerland
- German (fluent); good knowledge in English (written & spoken), knowledge in French & Italian is a plus
- Good knowledge of IT in order to work with databases and to prepare high quality documents
- Ability to work in a team
- Ability to analyze, organize and plan effectively with good communication skills
- Independent and solution-driven working style
- Commercial awareness and good information management skills
- Scientific university degree preferred (natural sciences or pharmacy)
**YOUR APPLICATION**
**Location**:
Switzerland : Zürich : Zurich
**Division**:
Consumer Health
**Reference Code**:
792576
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