Associate Director Regulatory Affairs CMC Biotech

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Associate Director Regulatory Affairs CMC Biotech

In Bayer's Pharmaceuticals division, we focus on researching, developing, and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology and ophthalmology. With our innovative products, we seek to achieve therapeutic benefit for patients, while at the same time satisfying the growing requirements of physicians and health insurers. As one of the leading research-based pharmaceutical companies worldwide, we have nearly 50 ongoing development projects in clinical trials.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Assoc Dir RA CMC Biotech are to:

• Represent RA in various cross functional teams, including CMC development teams, product supply teams, global regulatory teams;
• Responsible for independently forming and implementing the regulatory strategy for all "major" and emerging markets, regarding Chemistry Manufacturing and Controls (CMC) for assigned products in close cooperation with the relevant global, regional, and country RA functions, Product Supply, Medical, Drug Safety and Marketing;
• Ensure early identification of major regulatory hurdles and issues with regard to CMC related topics, regulatory guidelines and legal requirements, and coordination of respective corrective actions;
• Provide active input into GRT's and provide resolution for escalation topics for assigned projects to ensure timely submission and strive for first cycle approval;
• Responsible for timely availability and final content of CMC IND/IMPD, NDA/MAA/BLA or dossier variations for assigned products to Health Authorities, including responses to health authority questions;
• Responsible for the CMC change management for assigned development and marketed products, which includes tracking of CMC changes and processing of requests for related documentation (evaluation, consolidation, prioritization and review), responsibility for coordination of responses to health authority questions, and for implementation of CMC changes after HA approvals with product supply, to ensure regulatory CMC compliance;
• Mentor less experienced/newcomers within the RA CMC organization and driving close alignment of
• CMC activities across the Therapeutic Areas;
• Propose and implement standards concerning CMC documentation in close co-operation with global, regional, and local RA functions, and Product Supply;
• Responsible for achieving assigned global regulatory affairs project objectives (typically VS1.2 more projects, or projects of more complexity, than those of a VS1.2);
• Ensure adequate surveillance of the CMC related regulatory environment for assigned products and anticipate and influence changes in this environment globally by proposing strategies to CMC management to address and prepare for the regulatory changes;
• Timely availability and appropriate final content of CMC sections of submission dossiers directly influences time to market for Biotech products and especially potential block buster products. Non-compliance (of CMC) has potential to severely inhibit / stop product sales for individual products and assigned part of Bayer portfolio.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks and incumbent who possesses the following:

Required Qualifications:

• Bachelor's degree in life sciences
• Fluent in English;
• Excellent oral and written communication skills;
• Well developed management and leadership skills, as incumbent has to lead multidisciplinary teams;
• Demonstrated cross functional communication, interpersonal, influence, and negotiation skills;
• Ability to focus on multiple issues at one time and to organize and direct diverse activities in a changing environment often under time pressure Incumbent must be able to work focused and target oriented in a complex scientific / technical environment;
• Ability to harmonize and reconcile competing objectives to achieve the overall objectives;
• Thorough knowledge of company policies and procedures in drug development and maintenance;
• Incumbent must have thorough knowledge of the pharmaceutical industry, the company s strategic marketing needs, business practices and processes;
• Incumbent ideally has RA experience with biotech products/devices;
• Demonstrated originality in problem solving as applicable to drug regulatory issues;
• Skills and experience in dealing with Drug Regulatory Bodies;
• Strong analytical skills, and well-developed project management skills;
• Ability to work within a global team framework and a multi cultural environment;
• Work directly with different hierarchical levels within Bayer, ability to establish relationships between individual departments is essential;
• The job holder must be able to absorb large amounts of information efficiently, give sound judgments and remain calm in order to manage difficult situations effectively;
• The position requires scientific and technical expertise, including the ability to develop robust regulatory timelines and action plans;
• Knowledge of drug regulations and guidance documents on drug development and license variations in all main countries is required especially for biotechnological products;
• Knowledge of regulatory expectations in ICH/non ICH regions is highly desirable.

Preferred Qualifications:

• Ph.D., PharmD, or equivalent scientific degree, with 10 years pharmaceutical industry experience of which includes five years of relevant RA experience, especially with biotechnology products or Master's of Science degree in life sciences with 12 years pharmaceutical industry experience, Bachelor's degree in life sciences with 14 years pharmaceutical industry experience; either of which includes 7 years of relevant RA experience, especially with biotechnology products.
• Additional language is an advantage, preferably German.

Employees can expect to be paid a salary of approximately between $123,000 to $200,500. Additional compensation may include a

bonus or commission (if relevant). Other benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. If selected for this role,

the offer may vary based on market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other

relevant factors.

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