MANAGER GLOBAL REGULATORY COMPLIANCE

Job Responsibilities:

Develops, communicates and drives implementation of regulatory compliance
strategies to ensure postmarketing surveillance vigilance, adverse event
reporting, risk management, change control, promotional review, labeling,
document management and product development processes and systems are compliant
with relevant regulatory requirements. Manages the capture and provision of
regulatory intelligence and regulatory process and systems training programs to
appropriate QMRAEHS and ConvaTec staff, particularly in relation to adverse
incident reporting, document management, promotional material and labeling
review systems and processes. Supports regulatory audit activities in terms of
audit readiness, preparations, participation and followup. Supports and
coordinates regulatory input into change control, risk management and
continuous improvement activities. Builds relationships with quality
management, medical, legal, technical, product development, business groups,
and regulatory groups worldwide. Qualified incumbent will be expected to manage
skillful negotiation of agreements with internal customersand other BMS
divisions and continuously build and foster relationships and partnerships with
internal customers, external customers, stakeholders and support g roups
globally to address the changing business culture and regulatory environment.
This position is expected to make continuous improvement recommendations to
improve Regulatory work processes based on knowledge of BMS, ConvaTec and
external experiences. Must have a strong functional and technical understanding
of regulations and apply that knowledge when anticipating impact of regulatory
decisions on the Regulatory organization and ConvaTec as a whole. Qualified
candidate will have a demonstrated successful work experiences as team leader,
setting up roles and responsibilities, providing direction, and assuring
results are produced. Must be able to think in a clear, decisive manner,
remaining calm under adverse conditions.

Job Requirements/Education:

BS degree in life sciences or related field, with 5 to 7 years experience in
the Quality Assurance andor Regulatory Compliance arena in a medical device,
pharmaceutical, OTC or cosmetic company. Legal background or training is a
plus. Must have strong working knowledge of the healthcare industry, quality
systems, promotional compliance and the governing rules and regulations. Must
understand business principles and practices and how customer and compliance
activities interrelate with these principles and practices. Experience in
postmarket surveillance vigilance and or regulatory document management systems
is required. Qualified incumbent will possess the ability to be resilient under
pressure while maintaining a strong sense of integrity and respect for others.
This particularly relates to the review of promotional materials and when
providing regulatory guidance. Must have demonstrated ability to adapt
continuously and seamlessly to environmental changes as well as the ability to
collaborate with associates from acrossthe global QMRAEH and broader ConvaTec
BMS organization.

Salary will be commensurate with experience.
Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D