Regulatory Affairs Associate Temporary

Position: Regulatory Affairs Associate - Temporary

Location: Madrid

Experience: 3 years of experience in similar roles within the pharmaceutical sector

Want to know more

Exeltis is part of Insud Pharma a global pharmaceutical group operating across the entire value chain with extensive expertise in scientific research development manufacturing sales and marketing of a broad portfolio of pharmaceutical products that bring value to human and animal health.

Insud Pharma is organized into three synergistic business areas: Industrial (Chemo) Branded (Exeltis) and Biotech (mAbxience). With more than 10000 professionals in over 50 countries 20 industrial plants 15 specialized R&D centers 12 commercial offices and more than 35 pharmaceutical subsidiaries the group serves 1150 customers in more than 110 countries worldwide. Innovation and sustainable development are at the heart of everything we do.

What are we looking for

At Exeltis we are looking for a Regulatory Affairs Associate to provide regulatory leadership and overall management for LPRI projects developed for international markets. This person will play a key role in regulatory strategy definition submission planning and agency interaction ensuring high-quality filings and efficient approvals.

The challenge!

• Provide regulatory leadership for LPRI projects intended for international markets.
• Develop and implement regulatory strategies for projects in development.
• Act as the main point of contact with regulatory agencies.
• Provide regulatory advice on clinical development and submission of marketing applications to European Health Authorities.
• Maintain a thorough understanding of EMA regulations related to medicinal products medical devices or combination products.
• Share regulatory updates from EMA and other relevant international markets including the US with partners and collaborators.
• Plan and oversee the preparation of all regulatory filings for LPRI projects in Europe.
• Work closely with the Product Development team to ensure submissions are accurate complete and of the highest quality to support fast and secure approvals.
• Ensure that deficiencies and regulatory questions are addressed efficiently and within timelines.
• Manage eCTD submissions new filings and variations in collaboration with internal and external stakeholders.
• Perform regulatory due diligence assessments for potential product acquisitions or partnerships in the EU region.
• Actively contribute to regulatory process improvement initiatives within the department.

What do you need

• Degree in Sciences preferably Pharmacy or a related field. Masters degree is a plus.
• Fluent English and Spanish. Knowledge of additional languages will be considered an asset.
• 3 years of experience in similar roles within the pharmaceutical industry with exposure to international environments. Proven experience within a Regulatory Affairs Department.
• Strong knowledge of Modules IV.
• Experience in technical records management and team coordination.
• Previous experience in generics or branded generics will be highly valued including copies or 505(b)(2) NDAs.
• Knowledge of international standards for drug registration.
• Experience with centralized and decentralized dossiers.
• Knowledge of international markets and distribution business is desirable.
• Strong leadership strategic thinking organizational skills and communication skills.
• High level of initiative proactivity and ability to make decisions autonomously.

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COMMITMENT TO EQUAL OPPORTUNITIES

At Exeltis we are firmly committed to equal opportunities and diversity. We promote an inclusive work environment and do not discriminate on the basis of gender gender identity age ethnic origin nationality religion sexual orientation disability or any other personal physical or social condition.