Regulatory Affairs Associate - Temporary

Insud Pharma; Madrid; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Exeltis, part of Insud Pharma, Madrid, is seeking a Regulatory Affairs Associate to provide regulatory leadership and manage LPRI projects for international markets. The role requires defining regulatory strategy, planning submissions, and liaising with agencies to ensure timely approvals.

Fluent English and Spanish are required, with 3+ years in the pharmaceutical sector and strong knowledge of EMA regulations and centralised/decentralised dossiers. This is a temporary position in Madrid.

Formación

• Degree in Sciences (Pharmacy preferred); Master’s a plus.
• Fluent English and Spanish; additional languages a plus.
• 3+ years in pharmaceutical Regulatory Affairs with international exposure.

Responsabilidades

• Provide regulatory leadership for LPRI projects for international markets.
• Develop and implement regulatory strategies for development projects.
• Coordinate with regulatory agencies and plan filings for Europe.
• Oversee eCTD submissions and variations with stakeholders.
• Support product acquisitions and regulatory process improvements.

Conocimientos

Regulatory leadership

Cross-functional coordination

Regulatory submissions

Educación

Pharmacy degree

Master’s degree

Herramientas

eCTD submissions

Descripción del empleo

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 10,000 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 1,150 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. Master’s 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 I–V.


• 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.

Do you think this opportunity is not for you?

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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.