Senior Manager
Il y a 6 mois
**WHO ARE WE?**:
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 53,000 employees globally who nurture a diverse, collaborative, and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.
ROPU MIDI is a Regional Operating Unit consisting of 7 mid-sized Operating Units: Belgium, Denor (Denmark & Norway), Finland, Greece, Portugal, Sweden, and The Netherlands. MIDI is a multicultural and diverse work environment. More than 1.800 employees are striving to work together to improve lives for patients and animals in our region.
***THE OPPORTUNITY - DO WORK THAT MATTERS**:
You are looking for a new professional challenge and you would like to participate in Regulatory Affairs to the development, marketing and maintenance of innovative biologicals products? Join us and put your skills at the service of a global Animal Health team.
This is a global role, which means that you will work closely with other countries worldwide, and more particularly in Europe and France, where travels will be regularly required. For Netherlands and Belgium, the position will be possible as a full remote contract, with occasional travels to the local BI site (Amsterdam / Lelystad for Netherlands, Bruxelles / Evergem for Belgium).
***YOUR KEY RESPONSIBILITIES**:
The job encompasses the following main roles:
- As RA Research Advisor, you define what could be the best regulatory pathway for a novel concept as well as identify potential killers to avoid late dead-end, and especially for new modalities such as novel biotechnologies.
- As RA Project Leader and RA Product Manager, you are responsible for defining regulatory strategies and requirements for initiatives requiring an expertise in regulations of respective modalities in EU and other assigned geographies, anticipating the changes of the regulation environment that could impact the project or product.
- For the Senior Expert: As Mentor, you participate to the development of the RA mentees sharing your experience and expertise, developing their critical view, taking the right decision.
- With your expertise in Biologicals/Vaccines you are responsible for all regulatory aspects from development of new products to change management of existing products in Europe and assigned geographies.
- You write, review and approve development, maintenance and supporting documents, about quality, safety and efficacy parts, from a regulatory perspective.
- You are accountable for EU procedures, from pre-submission activities, over dossier preparation to the end of the procedure working in close cooperation with the different stakeholders within Boehringer Ingelheim, and with European Medicines Agency and local authorities externally.
- You are the key point of contact for internal and external stakeholders regarding technical and procedural regulatory aspects. You monitor emerging regulatory trends and integrate new requirements into registration and approval strategies, evaluating the possible risks related to the regulatory environment, and providing strategies to manage them.
In addition, your seniority level will allow you to successfully manage the following roles:
- You act as global regulatory representative in interdisciplinary teams, and lead regulatory project teams to complete new product development with success.
- You lead cross-functional or cross-organizational topics and project teams to build and maintain global processes and relationships for regulatory affairs aspects.
- You anticipate changes in the regulatory environment and evaluate the impact on projects and existing products.
- Furthermore, you cultivate professional working relationships with regulatory authorities and represent the company’s interests in external forums such as industry associations, paving the way to influence new regulations.
***WHAT YOU SHOULD BRING TO THE TEAM **:Doctoral degree in veterinary medicine or life sciences (e.g. Pharmacy, Biotechnology, Biology) is preferred, but you can justify similar advanced background in life sciences through equivalent educational or acquired experience.
Depending on the seniority level:
Biological Development and regulatory experience
- At least 7 years of experience in Regulatory Affairs, in charge of the development of Biologicals/Vaccines, with an excellent knowledge of EU regulatory legislation and requirements for the development and maintenance of Biologicals
- Good knowledge of regulations outside of EU
- Experience with authorities and regulatory forums
- Competences in the strategic evaluation of new regulations and regulatory trends, as well as their impact on the portfolio of products or projects in development Proven successful experience with European regulatory procedur
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