Director of Regulatory Affairs - CMC Lead, RDBU
Under the direction of the Senior Director of Regulatory Affairs, direct and manage Regulatory Affairs activities for developing and executing CMC strategies across product life cycles. Manage submissions and interactions with the FDA and other regulatory agencies for CMC issues. Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs, and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they may be studied and marketed as planned. Coordinate or oversee preparation of regulatory documentation in a timely manner to meet corporate objectives.
* 25%:Develop CMC regulatory strategy and manage regulatory activities and timelines for investigational and marketed products.
* 25%:Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies.
* 25%:Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to ensure conformance with regulations and existing regulatory approvals.
* 25%: Provide CMC regulatory guidance to Project/Product teams.
Education & Experience Requirements:
* M.S. / Ph/D. in biochemistry, chemistry, biology pharmacy, or related pharmaceutical field.
* Minimum of 7 years experience in pharmaceutical product development with a minimum of 4 to 5 years in leadership CMC regulatory affairs and a strong biologics background.
* Medical Device and/or Combination Product experience desirable.
* Significant experience in directing interactions with regulatory authorities.
* Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance.
Key Skills and Competencies:
* Ability to manage complex projects, timelines and teams in a matrix team environment.
* Excellent analytical and communication skills both verbal and written. Ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.