Junior Global Regulatory Strategist

Bayer AG; Województwo pomorskie; Hybrid; PLN 174,000 - 261,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Bayer AG in Poland invites applications for a Junior Global Regulatory Strategist to prepare and coordinate regulatory documents for local Health Authorities and support international development under the Lead Global Regulatory Strategist.

You will standardize processes, develop regulatory strategies for submissions, and communicate with authorities while working in a multicultural global team. The role offers a hybrid model with opportunities to grow in regulatory affairs.

Qualifications

• University degree in technical discipline or life sciences.
• Several years of regulatory, clinical or biomedical research experience.
• Experience in the pharmaceutical industry.
• Knowledge of Veeva RIM is beneficial.
• Understanding of drug development and regulatory guidance documents.
• Fluent in English (spoken and written).

Responsibilities

• Standardize Regulatory Affairs Strategy processes across international and ICH regions to streamline submissions.
• Develop regulatory strategies for Health Authority submissions for assigned regions.
• Support country or regional Regulatory Affairs for international development.
• Identify regulatory risks and coordinate with regional and global functions.
• Act as interface with Health Authorities and between regional colleagues.
• Coordinate regulatory input into lifecycle management for projects.
• Ensure timely approvals and robust agreements with stakeholders.
• Communicate regulatory requirements and mitigations to stakeholders.

Skills

Fluent English

Regulatory experience

Communication skills

Project management

Education

University degree in technical discipline or life sciences

Tools

Veeva RIM

Job description

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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 Global Regulatory Strategist

Position Overview:

As a Junior Global Regulatory Strategist, you will function within a Therapeutic Area structure, such as ophthalmology. Your role involves preparing and coordinating regulatory documents for submission to local Health Authorities (HA) for the registration and maintenance of new and existing products. This is done in close cooperation with your supervisor, ensuring streamlined processes and procedures across Regulatory Affairs under the leadership of the Lead Global Regulatory Strategist.

YOUR TASKS AND RESPONSIBILITIES:

• Standardize processes and procedures throughout all of RA Strategy Regulatory Affairs under the leadership of the Lead Global Regulatory Strategist for International and ICH countries to streamline registration request completion;
• Develop appropriate regulatory strategies for submissions to Health Authorities for the assigned regions;
• Support country or regional Regulatory Affairs as needed for international development;
• Ensure early identification and coordination of major regulatory issues impacting successful regulatory activities;
• Act as an interface to communicate with Health Authorities and as the primary interface between regional Regulatory Affairs colleagues;
• Coordinate international regulatory input into life-cycle management and maintenance activities for assigned projects;
• Ensure active feedback with robust agreements/approvals with/by regional and global functions for assigned tasks;
• Identify corrective regulatory measures and immediate actions required in case of deviations jeopardizing global Pharma goals;
• Consolidate assigned parts of regulatory strategy to achieve GRA project goals/milestones;
• Ensure information exchange with regions for assessment of regulatory requirements;
• Identify and communicate potential risks and mitigations associated with regulatory strategies to stakeholders.

WHO YOU ARE:

• University degree (Master or Bachelor with longer industry experience) in a technical discipline or in life sciences;
• Several years of experience in regulatory activities, clinical trials, or biomedical research activities;
• Experience in the pharmaceutical industry;
• Knowledge of Veeva RIM is beneficial;
• Understanding of drug development and regulations, guidance documents on drug development and license variations in main and assigned countries, and medical writing;
• Effective communicator with basic project management skills;
• Fast learner, open-minded, and challenges the status quo;
• High ability to solve problems and to structure and simplify complex tasks;
• Ability to work within a global team framework and a multicultural environment;
• Fluent in English, both written and spoken, other languages are helpful.

This position may be allocated across multiple locations, and elements of the recruitment process may vary to ensure compliance with local employment laws.

At Bayer, we are committed to transparency and equal pay for equal work or work of equal value. Due to differences in currencies and local compensation structures, detailed salary information will be shared with candidates during the recruitment process once they are identified as potential prospects. Final compensation is determined based on objective factors such as experience, qualifications, and scope of responsibility. This position is eligible for variable pay components, such as performance‑based bonuses, awarded in accordance with the applicable employee group, role scope, and compensation structure.

Benefits may vary depending on role and employment conditions.

YOUR APPLICATION

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Bayer offers the possibility of working in a hybrid model. We know how important work-life balance is, so our employees can work from home, from the office or combine both work environments. The possibilities of using the hybrid model are each time discussed with the manager.
Bayer respects and applies the Whistleblower Act in Poland.

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