Career Opportunities: BD&L liaison manager (11215)

Requisition Number 11215 

Posted 04/02/2014 

Location : Germany - Aachen - Drug Safety & Regulatory Affairs - Professional

Job-ID: 11215
Area: Drug Safety & Regulatory Affairs
Country: Germany
Site: Aachen


 

The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain treatment, its objective is to become the most patient-centric company and thus to be a leader in therapy innovation.
Grünenthal is one of the last five remaining research-oriented pharmaceutical companies with headquarters in Germany which sustainably invests in research and development. Research and development costs amounted to about 26 percent of revenues in 2012. Grünenthal’s research and development strategy concentrates on selected fields of therapy and state-of-the-art technologies. We are intensely focused on discovering new ways to treat pain better and more effectively, with fewer side-effects than current therapies.

Altogether, the Grünenthal Group has affiliates in 26 countries worldwide. Grünenthal products are sold in more than 155 countries. Today, approx. 4,400 employees are working for the Grünenthal Group worldwide. In 2012, Grünenthal achieved revenues of €973 mn.

In order to strengthen our Grünenthal team, we are currently looking for a

                                                    BD&L liaison manager.

 

Your responsibilities:

• Representing Global Regulatory Affairs in cross-functional pre-due diligence, due diligence and other project teams
• Providing strategic regulatory input and guidance during evaluation of opportunities in the pre-due diligence phase
• Accountable for an in-depth regulatory assessment of due diligence projects, flagging risks, proposing  mitigations, as well as highlighting opportunities for Grünenthal
• Providing critical assessment of and strategic input to key clinical, pre-clinical and CMC documents to maximize chances of success for approvals world-wide
• Providing strong regulatory guidance as well as developing and implementing smart regulatory strategies for product development and securing timely product approvals with a viable label taking into account the needs of the business and the patients
• With the support of a regulatory subteam, coordinating health authority meetings, CTAs and the submission and management of marketing authorization applications worldwide, with  focus on US, EU and Latin America.
• Assuming a proactive role in further shaping the department by identifying and leading projects to leverage further standardization and simplification of processes
• Monitoring trends and upcoming changes in the regulatory environment  and evaluating their impact for Grünenthal
• Having a central liaison function with subsidiaries, external partners and health authorities.

Your profile:

• University degree in Life Science (pharmacy, biology, chemistry or comparable discipline)
• Several years of experience in Regulatory Affairs within the pharmaceutical industry and/or with regulatory authorities,
• Preferably broad professional experience both pre- and post-authorization, in several therapeutic indication areas and across major territories (e.g. Europe, US, Latin America)
• Familiar with relevant guidelines and aspects of product development, especially in preclinical and clinical research.
• Understanding the added value of Regulatory Affairs for business overall
• Strong communication, negotiation and problem solving as well as conflict management skills
• Strong project management skills
• Ability to overcome obstacles to achieve key outcomes, and  to influence key decisions and persuade others
• Building effective partnerships and networks
• Open, flexible and adaptable personality, taking into account different mentalities and cultures

We offer an exciting and challenging role in an international environment where you can make a difference and where you can learn and grow.
If you feel that this is just the right job for you, please submit your application here online!

HR Contact:

www.grunenthal.com