BD (Becton, Dickinson and Company) Sr Director RA Infection Prevention in Vernon Hills, Illinois
Job Description Summary
The Senior Director, Regulatory Affairs, provides strategic regulatory guidance to cross-functional project teams responsible for product development and post marketing commitments. He/she defines and implements global regulatory strategies, translating regulatory requirements into practical, workable plans in order to facilitate timely drug development and registration. The Senior Director, Regulatory Affairs works with cross-functional project teams to execute the agreed-upon strategies; interacts with regulatory agencies to negotiate agreements; coordinates the planning and conduct of regulatory agency meetings; and supports departmental activities with regards to clinical trial conduct and regulatory submissions. This senior position will also be a member of the Regulatory Affairs Extended Leadership Team (ELT).
Actively leads development and implementation of regulatory strategy plans and activities for assigned programs and coordinates strategy with RA project management for assigned regulatory projects.
Lead the Infection Prevention RA team (approx. 6-7 team members) regarding drug submissions strategies for new, investigational products as well as marketed products
Provide mentoring to the regulatory team supporting Infusion Disposables platform for the Medication Delivery Systems (MDS) business as it pertains to distribution of a IV fluid drug products
Represents the Infection Prevention platform on the Business Unit leadership team.
Ensures the overall program execution of high quality, effective IND, NDA/CTD and MAA and related regulatory submissions and responses to regulatory agency requests:
develops and tracks submission timelines with the R&D team, Regulatory Operations, etc.
actively participates in product development project teams, advising on regulatory strategy, submission preparation timelines, processes, and requirements
coordinates regulatory workflow
prepares paper and electronic submissions in cooperation with Regulatory Operations/Publishing to support development project plans and timelines
works closely with Regulatory Operations/Publishing to ensure electronic Common Technical Document (eCTD) compliance
reviews and approves protocols, reports, and various documents and materials (e.g., CMC, clinical, nonclinical, etc.) used in regulatory submissions to ensure compliance
reviews and leads preparation and support of international regulatory submissions
oversees preparation of regulatory submissions to ensure compliance with all FDA regulations and guidelines.
Serves as senior leader for assigned projects with the FDA and other regulatory agencies:
establishes and maintains contacts and effectively partners with FDA and other federal agencies to direct, co-ordinate and implement preparation of all regulatory submissions and provide regulatory support across all areas
proactively plans, executes and leads successful regulatory agency meetings and interactions per regulatory strategy
Identifies and monitors legislative, regulatory and policy issues, working closely with BD’s Public Policy team. Develops risk assessment plans. Develops and presents information to educate internal stakeholders about risk (e.g., corporate evaluations on regulatory risk-benefit, options for risk mitigation).
Develops and implements registration strategy plans and ensures cross-functional alignment with overall development plans.
Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (e.g., CRO teams and vendors); participates as a key member of Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and procedural cross-functional teams.
Works with development partners as required; assists in due diligence activities.
Provides regulatory support to Quality Assurance for FDA GXP inspections; and provides regulatory oversight during follow-up to inspections and audits to minimize potential for findings of non-compliance.
Participates in review of promotional and advertising materials, as required.
Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish a compliant culture.
Provides leadership and guidance by promoting teamwork, discerning hiring needs, as well as coaching, mentoring, training and developing regulatory staff and other team members.
Bachelors or Masters Degree in a scientific discipline
Preferred: Advanced degree; MS, PhD or PharmD.
Minimum of 10-15 years of regulatory experience within the pharmaceutical industry. Combination drug/device product regulatory experience a plus
Experience managing direct reports and successfully mentoring junior staff
Past experience in successfully filing and receiving FDA approval of new small molecule drugs
Ability to think strategically about new regulatory pathways, working closely with R&D and the business groups
Excellent communications skills; ability to work at the team level, to peers and also communicate regulatory plans with senior management
Proven track record designing and executing creative development strategies and programs for drugs
Comprehensive experience in the drug development process in the US and internationally
Experience in the post marketing area and related requirements.
Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in eCTD format.
Experience with international clinical trials and associated regulatory documentation.
Solid understanding and applied knowledge of regulatory requirements (FDA, ICH) for the development and approval of investigational products.
Excellent communication (written and verbal) skills; proven ability to deliver effective presentations concerning complex topics.
Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
Proven ability to collaborate across multiple functions and build effective relationships within a team/collaborative environment, with a high level of professionalism.
Willingness to travel up to 20% domestically and internationally.
Primary Work LocationUSA IL - Vernon Hills
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status