DRA Executive Specialist

THE POSITION

We are looking for a Drug Regulatory Affairs Executive Specialist in Hungary, Budapest:

Planned start date: January, 2027

Who will provide local Regulatory Affairs activities for Boehringer products registered in Hungary. Ensures compliance with internal and external regulatory requirements. Ensures timely submission of applications and regulatory compliance of the Operating Unit's (OPU) portfolio with local regulatory requirements to sustain continuous market supply and patient safety. Provides excellent expertise and knowledge of regulatory environment as well as contacts with local Health Authorities to support Boehringer lngelheim business in the OPU.

MAIN RESPONSIBILITIES

Registration activities:

• Ensure timely submission and successful registration of new Boehringer products in line with local requirements

• Develop and align local registration strategy within Med / QRPE and local business. Align strategy with ROPU / Regional function and TM RA.

• Keep close contact with other departments in Hungary to provide strategic regulatory advice and to streamline the processes related to SLCI and reimbursement for Boehringer products marketed in Hungary.

• Maintenance of existing national Marketing Authorizations in line with local requirements and global standards. (management of CRC, SPC variations, renewals, last renewals, HAR, responses to Deficiency letters).

• Review of external translations for CAP products of variations in Centralized Procedures.

• Giving support for other departments in Hungary to ease market access in Hungary, including input to reimbursement negotiations.

• Close cooperation with Marketing and Supply Chain Management for all Launch and Change implementation Processes.

Regulatory intelligence:

• Responsible to keep the Local Medical Director, R-OPU & Regional Head of RA and local business partners where required informed of new regulations or updates.

• Ensures a high qualified regulatory impact assessment in timely manner.

• Ensures that updates or new regulatory requirements are reflected in internal systems, Global Regulatory DB or other information sources so that these are addressed.

• Ensure Updating information in internal systems.

Authority

• Establishes, develops and maintains close relationships with relevant National Regulatory Authorities and other bodies/organizations/key stakeholders to facilitate and develop effective collaboration on all regulatory interactions and ensure promotion the interests of Boehringer lngelheim.

• Adequate reaction to any Authority Requests.

Compliance

• Ensures compliance and quality of local RA organization by ensuring a proper Quality System (aligned with QM&MR).

• Support local inspection readiness.

• Contribute to CAPA process as appropriate.

EXPERIENCE:

Relevant experience in the pharmaceutical industry, preferably in Medical Affairs, together with knowledge of drug development, pharmacovigilance, scientific affairs and/or regulatory affairs.

REQUIREMENTS:

• University degree in Life Sciences

• Knowledge of local and international regulatory affairs regulation.

• At least 1 year of relevant experience in pharmaceutical industry/CRO

• Excellent command of English and Hungarian languages

• Strong organizational and communication skills

• Proactive and assertive attitude

• Collaborative team player with strong networking skills

WHAT WE OFFER

Joining us means enjoying a competitive compensation package, opportunities to develop your expertise, an inspiring Smart+ office environment, and the flexibility of hybrid working.