Director of Regulatory Affairs

We are seeking a Director of Regulatory Affairs who will play a pivotal role in shaping the regulatory strategies that drive successful product development and approval across international markets. This is a fully home based role in one of the European countries where OPIS has it's affiliate.

What Youll Do:

• Act as a trusted regulatory advisor to clients providing strategic input and guidance for new product development.

• Lead the development and execution of regulatory strategies aligned with EU FDA LatAm and Asia-Pacific requirements.

• Manage and maintain effective relationships with Competent Authorities ensuring consistent high-quality regulatory interactions.

• Oversee and coordinate formal meetings with regulatory agencies including scientific advice oral explanations and advisory committee meetings.

• Review and approve key regulatory documents such as IMPDs Orphan Drug Designations PIPs and CHMP advice applications.

• Lead and contribute to scientific advice and orphan drug submissions attending meetings with authorities as required.

• Support business development by representing the Regulatory Affairs function in client meetings and bid defenses.

• Stay at the forefront of evolving global regulatory frameworks and GCP/GxP/ICH guidelines for clinical post-authorization and registry studies.

Who you are:

• You hold a scientific degree bringing with you an extensive foundation in pharmaceutical sciences.

• Minimum 10 years in regulatory roles within CRO settings

• In-depth understanding of ICH GCPs FDA and other regulatory body standards as well as regulatory requirements for a wide array of clinical studies (Phase I-IV PASS PAES).

• Proactive and solutions-oriented with the ability lead multiple complex projects.

• A strategic thinker who excels in customer service and cross-departmental collaboration with strong verbal and written communication skills.

What we offer:

We offer a competitive salary and benefits package as well as opportunity to be part of a company that values growth innovation and customer success.

Please read the information notice on the processing of personal data in the candidates information section of our company website.

Who we are:

OPIS is an International CRO with over 25 years of experience in conducting Phase I-IV non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.

OPIS extensive expertise covers all phases of drug-related trials taking care of the Sponsor beyond the therapeutic area offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world OPIS offers a full range of integrated clinical research services as scientific advice medical writing trial start-up monitoring study management data management statistics pharmacovigilance medical monitoring electronic data capture as well as quality assurance and training.

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