Senior Regulatory Affairs Specialist

POSITION PURPOSE

As the Senior Regulatory Affairs Specialist, you will be responsible for the preparation, submission, and maintenance of regulatory documentation in compliance with applicable legislation. You will coordinate cross-functional efforts to support product registrations and ensure ongoing compliance throughout the product lifecycle. This position also involves close collaboration with internal and external stakeholders and requires active monitoring of regulatory developments to ensure alignment with current standards.

KEY RESPONSIBILITIES AND DUTIES

• Compile, review, and update registration documentation in accordance with regulatory requirements.
• Coordinate with cross-functional departments to gather necessary data and ensure timely submissions.
• Manage regulatory procedures, including communication and coordination with internal teams and external regulatory bodies.
• Maintain product registrations and ensure timely updates throughout the product lifecycle.
• Monitor changes in regulatory legislation and industry trends, and support the integration of these requirements into company practices and procedures.

QUALIFICATIONS & REQUIRED SKILLS

• University degree in Pharmacy, Chemistry, or related field.
• Previous experience in Regulatory Affairs is an advantage.
• Knowledge of European pharmaceutical regulatory legislation.
• Strong decision-making, organizational, and communication skills.
• Ability to interpret and apply relevant legal and regulatory requirements.
• High attention to detail and a collaborative working style.

Our Recruitment Process: 

To be considered for this role, please apply in our Applicant tracking system and refrain from sending your CV via email. Upon the completion of sourcing (CV collection) period, all received application will be reviewed by our Recruitment experts and evaluated against the needs of the open role. Successful candidates will be contacted by our Recruiting experts for an initial screening interview during which further details about the selection process will be shared. Successful candidates will progress to interviews with line managers, while not selected candidates will be informed in a written form as soon as possible. 
Diversity is a fact. Inclusion is an act @Zentiva
 
At Zentiva, we are a team of 5000 unique talents bonded together by our purpose to provide health and well-being for all generations. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. 

Join our winning team! Be a part of our winning culture! Be Zentiva!