Associate Director Regulatory Affairs .
Sever Pharma Solutions provides long-standing experience in the technologically demanding area of polymer-based delivery systems. In this area, experience makes the difference because explicit dosage form-related regulatory guidance is lacking; selection and sourcing of polymeric excipients is an expertise in itself; and interactions between polymer and drug substance may be complex.
Sever Pharma Solutions has unique (co)-extrusion capabilities, the readiness to manufacture investigational medicinal products for clinical trials, and the ability to handle drugs in the highest occupational exposure bands.
It is their philosophy to be a transparent and flexible development partner, willing to step in at any point of the development process.
As in earlier stages of development, Sever Pharma Solutions work according to relevant regulatory guidelines and follow principles such as Quality by Design and Design Control for pharmaceutical products and devices, respectively. They are also highly experienced in the development of combination products and can help customer’s to navigate this regulatory pathway, providing relevant supporting documentation for their submission.
A key part of the later development of any pharmaceutical product is establishing a design space, whereby the influence of critical material attributes and process parameters on the final product is thoroughly understood. Sever Pharma Solutions can demonstrate that the product is manufactured to the highest quality. This knowledge is generated through applying a Design of Experiments (DOE) approach to development trials, to give maximum information with minimal effort. By continuing to partner with them in commercial manufacture, customers can be assured that this knowledge will follow the product through to production, resulting in the consistent manufacture of a quality product using a robust process.
Approval of the customers’ product is their common goal. They know what it takes to get there and have this goal in mind from the earliest stages of development. This makes the transition from earlier development to late development as smooth as possible for products that they have been involved with from the start. They can also work towards a seamless tech transfer of a product from another site and ensure that further development and manufacture is conducted according to the customers’ needs. Their experience includes the supply of batches for late phase clinical trials, process validation, and the manufacture of registration batches. Following approval of the product, they can take the step to commercial manufacture together with the customer.
Sever Pharma Solutions put the customer in focus, and give excellent service as part of their culture. One of their strengths is their ability to be flexible and solve challenges that arise during a project’s life cycle. Good communication with customers is one of the most important things to reach success.
Sever Pharma Solutions
- Lead regulatory activities for major projects and participate in multidisciplinary project teams
- compile required CMC documents (i.e. author, review and collect documentation) in compliance with EU and US regulations and guidelines, to support the technical content of regulatory submissions.
- Contribute (author, review and provide scientific input) in building a strategic development plan by providing the regulatory perspective and advise on risk-based approaches.
- Develop and execute well-defined and defensible regulatory strategies, for European, U.S. and national submissions, in order to accomplish customer’s regulatory and business objectives in an efficient and timely manner.
- Prepare and conduct regulatory meetings with health authorities, e.g. scientific advice, pre-submission or protocol assistance meetings.
- Contribute to the development of regulatory risk management recommendations and decisions.
- Set forth the impact (implications and consequences) and benefit-risk that emerge from proposed regulatory recommendations.
- Identify, analyse and interpret relevant law, regulations, and guidance documents covering regulatory requirements for pharmaceutical products and drug-device combination products (in development and/or registered products) and recognize potential regulatory issues, solutions, and opportunities.
- Analyse communications from health authorities and respond appropriately.
- Perform due diligence and regulatory gap analyses on candidate CMC development products and deliver advice how to reach critical CMC-RA development milestones.
- Review documentation from stakeholders for regulatory purposes and indicate the regulatory implications of the analysis.
- Contribute to the development of new or revised legislations and guidance documents and advocate SPS’ organizational position to decision-makers.
- assess regulatory needs for post-marketing submissions
- Participate in lifecycle management activities.
Profiel van de kandidaat.
- A Master’s degree in biological, pharmaceutical, chemical or engineering sciences is preferred.
- A minimum of 8-10 years of experience in the regulatory field, including relevant and demonstrable experience with drug products, combination products and/or medical devices is required.
- Direct and significant (8-10 years) experience in writing CMC documentation for INDs, ANDAs, NDAs and/or MAAs.
- In depth knowledge of ICH, EMA and FDA regulations and guidance on drug products and/or drug-device combination products.
- Direct experience in orchestrating and leading meetings with Health Authorities (EMA and/or FDA)
- Advanced knowledge of the pharmaceutical drug development process.
- Basic knowledge of how QbD principles can be applied in design space and further in the regulatory framework.
- Direct experience in developing regulatory strategies in compliance with regulatory requirements.
- In-depth knowledge of the registration procedures for drug and drug-device combination products in Europe and the US.
- Customer focussed.
- Team worker.
- Effective technical and regulatory writing skills to author regulatory CMC documents and reports.
- Fluid intelligence - ability to solve problems in novel domains with no previous knowledge.
- Ability to find effective solutions to deal with complex matters.
- Effective English oral and written communication skills to establish, maintain and further professional collaborative relationships with clients and other stakeholders.
- Ability to transfer information about complex technical regulatory issues clearly and in plain language to internal and external stakeholders.
- Ability to work autonomously, recognizing when to seek input and communicate effectively within a multi-disciplinary team.
- Multi-tasking skills – ability to set priorities and efficiently manage and deliver multiple projects simultaneously.
- Commitment to personal development.
If you are interested in this position and would like to know more about it, please contact:
Marjo Lucker, Recruitment Consultant
T: +31 6 13 56 19 88
Marije Hoogendoorn, Recruitment Specialist
T: +31 6 23 13 51 18