Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Director CMC Regulatory Affairs
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Director Chemistry Manufacturing and Controls Regulatory Affairs, are to:
- Be accountable for leading robust Chemistry Manufacturing and Controls (CMC) strategy efforts and for developing and driving the local and global regulatory strategy for CMC sections in collaboration with other local and global regulatory functions, Product Supply, CMC and biotech development functions as well as Clinical and Non-Clinical Development, as needed;
- Support the development of a Center of RA CMC Excellence for new modalities and build up new subject matter expertise for Bayer, including newly acquired biotech product lines to support Bayer’s recently announced research and development initiatives in the areas of Cell and Gene Therapy (CGT);
- Lead local and/or global health authority communications concerning CMC CGT development;
- Serve as representative for RA CMC in development teams and global regulatory teams for assigned projects in close alignment with all therapeutic areas;
- Be responsible for the final CMC content of health authority submissions and replies to health authority questions for assigned products;
- Ensure early identification of major regulatory issues in the area of CGT development and conduct appropriate management escalation as required;
- Assume responsibility for conducting due-diligence activities relevant to regulatory CMC aspects, in support of ongoing product acquisitions in the area of CGT
- Assist with efforts to ensure timely and adequate surveillance of both the local and global regulatory landscapes relative to CMC product development for Bayer’s CGT product portfolio;
- Represent Bayer on high profile, highly visible industry initiatives involving new technologies and their application to new product development, as applicable to CGT environment;
- Lead assigned global regulatory affairs project objectives;
- Be responsible in ensuring the adequacy and validity of CMC regulatory data in due-diligence reviews for potential in-licensing, the adequacy and completeness of technical CMC regulatory content is essential in determining the acceptability and risks associated with inhouse and in-licensing projects.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Bachelor of Science degree in life sciences with at least 12 years pharmaceutical industry experience or Master of Science degree in a Life Sciences field with at least 10 years of pharmaceutical industry experience or Ph.D. or Doctor of Pharmacy or equivalent scientific degree with at least 7 years of pharmaceutical industry experience;
- Possess strong knowledge and experience of pharmaceutical and Cell and Gene Therapy regulatory requirements pertaining to new product development;
- Strong scientific and technical expertise, including the ability to develop robust regulatory timelines and action plans covering both technical and strategic CMC activities;
- Ability to conduct in-depth and thorough review of technical documentation to support cell and gene therapy due diligence activities;
- Strong analytical regulatory skills;
- Be able to work focused and target oriented in a complex scientific / technical environment;
- Strong priority management skills including a proven track record to lead multiple issues at one time and the ability to organize and direct diverse activities in a changing environment often under time pressure;
- Be able to work within a global team framework and a multicultural environment;
- Well-developed leadership skills, including interpersonal and dispute resolution skills;
- Excellent communication skills, both verbal and written;
- Professionalism and organizational savvy, work directly with different hierarchical levels within Bayer;
- Proven ability to establish relationships between individual departments;
- Ability to process large amounts of technical information efficiently and provide sound judgments in order to manage complex problems effectively.
*This position offers Flexible work options*
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
State: South Carolina
Location: Residence Based
Reference Code: 446481
Functional Area: Regulatory Affairs
Entry Level : Professional