This position resides within Worldwide Pharmaceutical CMC and is accountable for pre-approval and post approval pharmaceutical products. This includes development support and life cycle management as pertains to the preparation and maintenance of the critical CMC section. In this capacity the incumbent works in new product development, maintaining approved products, including finished product and drug substance, site transfers and in line extensions. The incumbent is expected to remain current with regard to food and drug laws, regulations, guidelines, policy and pharmaceutical issues to anticipate changes in the US, EMEA, and international regions which may impact Merial and recommend appropriate action to protect Company interests. The incumbent is expected to lead by influence within Project teams to ensure alignment of the agreed upon CMC strategy.
The person will demonstrate leadership in interpreting and counseling R&D and line organizations on complex and evolving regulatory CMC requirements.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees
Duties & Responsibilities:
Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as Lifecycle management projects such as site transfers.
Participate in Project team and lead technical task force meetings leading on RA/CMC related activities.
Work to align with the RA Technical Director to research and prepare the initial CMC strategy for timely registration of New Product with FDA, EMA and other world Regulatory Authorities.
Provide leadership to rapidly adapt strategy to unanticipated changes.
Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation necessary for timely world-wide registration.
Work with functional experts to provide timely responses to CMC questions from regulatory agencies.
Support transfer of manufacturing processes and analytical methods from R&D to Industrial Operations.
Writes CMC dossier from CMC data package and coordinate a comprehensive project team review by functional team members to ensure accuracy of the filed dossier.
Participate in and manage post-approval product activities such as, but no limited to, change control, supplements and variations for global products as well as questions from regulatory authorities where appropriate.
Provide regulatory CMC expertise during Regulatory Affairs negotiations and interactions with regulatory agencies.
As CMC Technical representative to assigned New Product Development teams, communicate with internal and external customers to obtain required supporting documents and data for compilation of the CMC dossier in a timely manner that supports agreed upon project timelines.
Coordinate and lead the task of drafting responses to CMC related questions from FDA or foreign health authorities.
Represent BI position and interests in external trade organizations or regulatory professional societies. Keep up to date on industry and regulatory trends.
Provide regulatory CMC expertise during due diligence and in support of new projects.
Ph.D. from an accredited institute with four (4) years’ experience OR Master Degree from an accredited institute with six (6) years’ experience OR Bachelor Degree with eight (8) years technical experience in chemical disciplines within chemical research, analytical research, quality control, production formulation development, or product development.
Exceptional analytical and problem solving skills; extensive medical, scientific and/or technical knowledge pertaining to pharmaceutical development or operations good judgment; exceptional interpersonal skills with emphasis on diplomacy, negotiation and ability to work in a team-based setting; effective communication skills; flexibility; self-confidence, achievement-oriented with appropriate concern for quality are highly desirable qualifications.
Exceptional written and verbal communication skills including ability to persuasively communicate
Effective interpersonal skills with the ability to work in a team-based setting; flexibility; achievement-oriented with appropriate concern for quality are highly desirable qualifications.
Computer literacy required.
In addition to above: Record of achievement of regulatory approvals and demonstrated success in working with regulatory authorities and/or toll manufacturers.
In depth knowledge of U.S. and European Regulatory and pharmaceutical issues
CMC support of new pharmaceutical and/or marketed pharmaceutical products worldwide
Extensive customer interactions with R&D functions, QA, Manufacturing and other teams within Regulatory Affairs
External influence in trade organization or regulatory professional societies
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufact...uring.
At BI, our employees are committed to improving patients' lives. We do this through our dedication and passion for innovation. Our distinct corporate culture is rooted in our belief that in order to be successful we must have a strong partnership with our people therefore we strive to create a culture where our employees are encouraged to balance their work life with their personal life. Our success also depends on a diverse and talented workforce which is why we are committed to sustaining an organization that encourages diversity in all aspects of the business, whether that be in the diversity of the background of our employees, of thoughts and ideas or diversity of our partners and suppliers.