Senior Regulatory Affairs Manager, Allergy Category in Reading - Bayer

Job Overview

Reading, England
Job Type
Full Time
Date Posted
9 days ago

Additional Details

Job ID
Job Views

Job Description

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.

Senior Regulatory Affairs Manager, Allergy Category

Hybrid role, with some presence on site at Reading

Key Tasks and Responsibilities:
The Senior Regulatory Affairs Manager, Allergy Category is assigned a portfolio of Global NPD Allergy projects.
For each project, they are responsible for:
• Supporting proper and timely registration in identified countries
• Ensuring that product dossiers are properly prepared, maintained, and accessible
• Aligning of activity and effort with the regulatory strategy
• Ensuring that all registration data are entered into the proper data management systems
• Under minimal supervision of the Director Regulatory Category Allergy, he/she will manage timelines and deliverables for regulatory procedure submissions to Health Authorities.
• Assisting with the development of global regulatory strategies and timelines for assigned new projects and providing support to local affiliates with strategy formulation and registration requirements for said projects.
In doing so, they carry out or oversee the following activities:
• Ensuring that activities, plans, strategies, and outcomes are aligned with the Product Supply Consumer Care, Product Development (PD), Regulatory, Medical, Safety & Compliance (RMSC), and the Global Category Business Unit (Allergy) functions as appropriate.
• Manages the preparation of registration dossiers related to assigned projects and proactively identifies and tracks regulatory activities and /or issues and risks and brings these to the attention of RMSC management through the Regulatory Strategy Document and other means as necessary
• Liaise with RMSC Global Medical Affairs and Evidence Generation to assist local countries in substantiating claims
• Implement appropriate Bayer Consumer Care and RMSC business policies, processes and standard operating procedures
• As assigned by the Director Regulatory Category Allergy, provides regulatory expertise to and oversees the work of Regulatory Specialists supporting the aligned projects
• Regularly reports status measures to the Director Regulatory Category Allergy, and appropriate stakeholders

Who you are:
• A degree in the life sciences
• Post graduate degree is preferred but not required
• Extensive experience in comparable position
• Proven regulatory experience in consumer health care
• Experience in European regulatory procedures (i.e., National, Mutual Recognition, and Decentralized). Experience with Health Authorities in LATAM and APAC highly desirable
• Experience with drug and medical device regulations preferred
• Demonstrated ability to articulate and formulate solutions for regulatory issues
• Proficiency in MS Office: Word, Excel, PowerPoint
• Ability to expand regulatory procedure knowledge to include additional regions
• Ability to grow in leadership capabilities
• Ability to communicate effectively in English both verbally and in writing
• Ability to work as a member of a team
• Results orientation

Your Application:
Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.
To achieve our vision we see reward for all our employees as incredibly important and include the following list of benefits and working conditions:
competitive salary and performance bonus28 days annual leave plus bank holidaysPrivate Healthcare, generous pension scheme and Life InsuranceEmployee discount scheme
State of the art offices International career possibilitiesFlexible and hybrid working

Are you up for the challenge? If so,  please apply below.

United Kingdom : Berkshire : Reading

Consumer Health

Reference Code:


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