Associate Director, Regulatory Affairs Marketing Authorisation

Associate Director, Regulatory Affairs Marketing Authorisation

Laminar Pharmaceuticals

Palma de Mallorca, Spain

Founded in 2006, Laminar Pharmaceuticals (Laminar) is a Phase II/III biotech company focused on the development of new molecular treatments based on a novel therapeutic platform, melitherapy. Our team is deeply committed to identifying, developing and bringing to patients novel therapies for the treatment of pathologies with unmet clinical needs, like rare cancers and neurodegenerative disorders. We have offices in 2 countries and a headcount of 31 employees. We are currently looking to recruit an Associate Director, Regulatory Affairs Marketing Authorisation.

Responsibilities of the role include:

The Associate Director, Regulatory Affairs Marketing Authorisation is primarily responsible for providing strategic and operational direction, oversight and hands-on, day-to-day support for the planning and execution of Global Marketing Authorisation activities for Laminar products. Working closely with the Global Head of Regulatory Affairs, as well as cross-functionally, this individual:

• Understands the regulatory requirements and is responsible for the management of Regulatory activities for registering Laminar products on a global scale, including strategic input, audits/inspections, and product life cycle management activities;
• Participates in the regulatory submission and agency interactions;
• Coordinates the regulatory strategy for the preparation and submission of the registration dossier for marketing approval by centralised procedure of the Laminar’s Lead compound, idroxioleic acid;
• In alignment with Laminar’s global regulatory strategy, assists in the development and implementation of regional/global regulatory strategies for Laminar products in all stages of clinical and commercial development, focusing on the EMA region;
• Manages the preparation of new and pending IMPDs and INDs, and Compassionate use/Expanded Access programs;
• Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions;
• Coordinates preparation of meeting packages and response strategies to Health Authorities, and for liaising and negotiating with global regulatory authorities;
• Collaborates with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations; and
• Performs other tasks and assignments as needed and specified by the executive team.

Requirements for the role include:

• Bachelor’s degree in a relevant discipline and a minimum of 8 years of relevant Regulatory Affairs professional experience in a pharmaceutical, biotechnology, CRO, or related environment with at least 2 years of leadership experience in EMA Regulatory Submissions;
• Prior experience helping to build a regional Regulatory Affairs function for a growing organization;
• Ability to analyse and interpret scientific data and regulatory guidelines. In-depth knowledge of relevant EMA and regional (EU-5) regulatory guidelines and requirements;
• Demonstrated, hands-on experience managing and preparing all phases of regional/country-specific regulatory submissions including knowledge of Centralized procedures;
• Demonstrated track record of success in building relationships with, and influencing, regional and/or national health authorities, particularly in situations requiring direct interaction/negotiation;
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members;
• Proven track record of project management and change management, including the ability to support and prioritize multiple projects;
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines;
• Strong oral and written communication, managing and adhering to timelines, negotiation skills, integrity and adaptability.

*Special knowledge or skills and/or licenses or certificates preferred.

• Experience in Oncology Therapeutic Areas;
• Experience in rare or orphan disorders research (small patient populations coupled with urgent unmet medical need);
• Solid working knowledge of drug development process with experience with non-commercialized small molecules;
• GMP, GCP and GDP awareness;
• Experience with product launch activities;
• Experience with Early/Compassionate or Expanded Access Programs;
• Knowledge of FDA and ICH regulatory requirements.

What’s in Laminar for you:

This is a great chance to work in a growing biotech company that invests heavily in its staff and is committed to patients healthcare. Laminar is a pioneer in the development of new therapies based on a novel approach, melitherapy. We expect to request the conditional marketing authorisation for LAM561 during Q1 2024 and, if it is approved, launch our first marketed product thereafter. Therefore, this is an excellent time to join a motivated and engaged team to complete this last stage.

The base salary range is based on the candidate’s professional experience level. The candidate will hold an employment contract with the Spanish office. The job will preferably be located at the offices in Palma de Mallorca (Spain) to facilitate close contact with the office team, but remote work can be considered.

Laminar Pharmaceuticals embraces diversity, equal opportunity, reconciliation of work and family life, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age, and disability.

Interested candidates can submit a cover letter and CV to hrm@laminarpharma.com with the subject: Associate Director, Regulatory Affairs open position application.

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