Regulatory Affairs Specialist

POSITION PURPOSE
As the Regulatory Affairs Specialist, you will prepare, compile, and submit under supervision high-quality post-approval regulatory applications in compliance with EU and other national requirements. You will participate in defining regulatory strategies for the preparation of post-approval applications and provide regulatory support to project teams and key internal and external customers.

Main Accountabilities And Duties

• Preparation, compilation, review and submission of high quality regulatory applications in accordance with EU and national requirements and legislation with limited oversight.
• Track and monitor queries/deficiency letters/commitments from/to Regulatory Competent Authorities to ensure these are implemented and conformed to in a timely manner.
• Communicate critical regulatory information for assigned projects before, during and after approval until the point of handover to regulatory maintenance teams.
• Develop and maintain a thorough and up-to-date understanding of the regulatory environment and supporting data requirements.
• Align resources and discusses regulatory issues in cross-functional teams to ensure completion of project tasks.
• Communicate with peers and supervisors and ensure alignment on issues, questions and goals.
• Employ effective technical and regulatory writing skills to author standard regulatory documents and reports.
• Preparation for and participation in meetings with internal and external stakeholders.
• Provide regulatory support to project teams, stakeholders and customers, as required.
• Evaluate the regulatory environment and contribute to providing internal advice and regulatory information throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
• Review written correspondence from peers and entry-level employees.
• Provide regulatory input and appropriate follow-up for inspections and audits.
• Identify the need for new regulatory procedures and SOPs, and participates in development and implementation

Qualifications & Required Skills

• University degree in Pharmacy, Chemistry, or related Natural Sciences.
• 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