Regulatory Affairs Manager New Initiatives

Wörwag Pharma – a medium-sized, internationally active, family-owned pharmaceutical company headquartered in Böblingen near Stuttgart, Germany, which recognized and scientifically proved the importance of biofactors very early on. For more than 50 years, we have been fighting the civilization diseases of our time - preventive, accompanying, healing. Our slogan "Getting closer helping better" is not just a promise to doctors, pharmacists and patients. It is an expression of our colorful corporate culture and our collegial cooperation among our now 1,200 employees worldwide.

Become a part of our team in our headquarter in Böblingen (near Stuttgart) because we are looking for you as a

These tasks await you

• Review & strategize assigned new submissions, in-licensing projects and other initiatives, identify peaks & adjust timings/priorities where possible without/minimal commercial impact
• Communicate & act as point of contact towards stakeholders regarding defined New Initiatives & Innovation (NII) related topics & projects
• Independent, self-driven planning, preparation and execution of regulatory activities mainly related to new marketing authorisations applications worldwide according to agreed timelines. This includes:
• Defining the regulatory and pharmaceutical requirements for submissions in close cooperation with local Regulatory colleagues & consultants,
• Creation, compilation and maintenance of regulatory documents for registrations
• Running and coordinating application procedures including post-approval variations required for the launch of new products
• Coordination and preparation of timely of responses to questions of health authorities
• Maintenance and update of regulatory files and databases in accordance with legal obligations and internal standards.
• Close cooperation and communication with other departments, consultants, CMOs as well as with affiliates, including pro-actively advising on potential regulatory risks and recommending the best regulatory strategy
• Keeping abreast with changes to the regulatory landscape and requirements and communicate relevant changes to internal stakeholders
• Actively contribute to important department deliverables such as strategy development, budgeting, compliance activities, improvement of intra- & interdepartmental collaboration, optimizing internal process & standards etc.

What you bring with you

• Completed degree in pharmacy, human or veterinary medicine or other health-related science; Master of Drug Regulatory Affairs is a plus
• At least 3-4 years of professional experience in Regulatory Affairs in the pharmaceutical industry or in a regulatory authority
• Very good knowledge of technical & regulatory requirements and experience regarding new marketing authorisation applications for medicinal products at least in EU and ideally also in other regions
• Ability to negotiate approaches & responses to health authorities in a manner acceptable to both the regulatory agency and the company demonstrated by a proven track record of getting registrations / variations successfully approved 
• Experience in working with regulatory information management systems & databases; good understanding of eCTD requirements and submission compilation
• Accurate, analytical, independent, integrative and responsible working practices, value-oriented & entrepreneurial thinking and acting 
• Demonstrated excellent organization and project management skills, ability to work in a team and to complete tasks in a detail-oriented manner with high standard despite tight deadlines
• Excellent English communication skills (both oral and written; German and further languages an advantage); able to communicate effectively to convey complex technical information to various internal stakeholders and to discuss/present expert matters confidently

We offer you

• A dynamic, international environment with the opportunity to take on responsibility quickly and extensively, to contribute experience and knowledge and to implement ideas
• Varied challenges, as well as exciting projects with a strong team spirit
• Compensation in line with the market and your performance, as well as additional benefits which can be used flexibly according to your needs, e.g.,   
  • Subsidy for direct insurance
  • Individual compensation options for days off, pension provisions or payout
  • Bonago vouchers for special occasions
  • Support for your general well-being and/or work-life balance
  • Health-promoting measures such as discounted conditions on over-the-counter (OTC) pharmacy products or health days
• Flexible trust working hours as well as the possibility to work mobile up to 60% of your working time 
• Central company headquarters with free parking facilities, good public transport connections as well as mobility allowances
• A wide range of opportunities for personal and professional development
• Regular employee events

We are looking forward to receiving your application