Career Opportunities: International Regulatory Project Lead (11195)

Requisition Number 11195 

Posted 04/02/2014 - Germany -

Aachen - Drug Safety & Regulatory Affairs - Professional

Job Description Print Preview

 

Job-ID: 11195
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 an

                                                    International Regulatory Project Lead.

 

Your Responsibilities

• Accountable for the development, planning and execution of the overall global regulatory strategy for a product/group of products, designed to deliver timely approvals with a viable label, taking into account the needs of the business and the patients
• Ensuring commercial engagement with proposed regulatory strategies; flagging risks, proposing  mitigations, as well as highlighting opportunities for Grünenthal
• Responsible for interacting with stakeholders from e.g. Drug Safety, Quality Assurance, Supply chain, Production and other key functions, and representing Global Regulatory Affairs in cross-functional product teams
• Accountable for leading, facilitating and coordinating the regulatory subteam, as well participating in the skill development, coaching, and performance feedback of team members
• With the support of the regulatory subteam, smartly managing all life-cycle management activities, such as e.g.
  • developing fit-for-purpose submission strategies to secure and earliest possible approval of key deliverables at minimized costs,
  • providing critical assessment of and strategic input to key clinical, pre-clinical and CMC documents to maximize chances of success for approval
  • preparing submission packages for marketing authorization, variation and renewal applications world-wide,
  • managing all regulatory procedures (CP/DCP/MRP or national),
  • coordinating health authority meetings where appropriate
• Supporting due diligence and partnering activities, as assigned
• 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 the regulatory authorities, preferably pre- and post-authorization.
• Familiar with relevant guidelines and aspects of life cycle maintenance, preclinical and clinical research.
• Regulatory experience in a global setting, main territorial focus: European Union, Latin America and international markets
• Preferably experience with several therapeutic indications, e.g. pain, CNS, inflammation
• Understanding the added value of Regulatory Affairs for overall business
• 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
• Ability to link long-ranging visions and concepts to one’s daily work
• Building effective partnerships and networks
• Open, flexible and adaptable personality, taking into account different mentalities and cultures
• Strong in teamwork
• Analytical, structured but pragmatic working style
• Fluent Business English skills, Spanish beneficial

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