Sr. Manager/Manager Regulatory Affairs, Sterile Products
Chestnut Ridge, NY
96 - Regulatory Affairs
Direct Reports (list)
Reports to (title)
SVP, Regulatory Affairs
To be completed by Corporate Compensation:
FLSA (USA only)
Job Summary - a concise overview of the job
The Sr. Manager/Manager, Regulatory Affairs, Sterile Products is responsible for the oversight and coordination of regulatory efforts relating to the compilation, review and submission of ANDAs, amendments, and post approval supplements including REMS submissions, to support the Company’s internal and external R&D pipeline and approved products. Additionally, the Director will be responsible for assisting with the final review of department submissions, as well as assisting with decision making on complex CMC issues.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Par Sterile sites – Rochester MI and Bangalore, India
US branded and generic product portfolio; may advise on global portfolio
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
+ Oversee and manage regulatory activities and drive project time lines to coordinate the compilation, review and submission process for ANDA’s, subsequent amendments, including SPL/PLR (labeling), all interactions and communications with the FDA from product inception to approval, including regulatory support during Pre-Approval Inspections for assigned projects.
+ Oversee and manage all REMS regulatory activities, including attendance and participation at related meetings and compilation and review of REMS submissions to FDA.
Post Approval Submissions
+ Oversee and manage regulatory activities and drive project time lines to coordinate the compilation, review and submission process for Post Approval submissions, including SPL/PLR (labeling), including all interactions and communications with the FDA, including final review and approval of these submissions.
+ May participate in product launch preparation.
+ Provide strategic regulatory input for product issue resolution, coordinate, prioritize, and provide day-to-day regulatory support throughout product life cycle.
+ Provide strategic position/landscape for new products as well as identify and reduce internal/external barriers to accelerate the approval process.
+ Advise project teams and regulatory department members of potential areas of concern and new governmental and regulatory developments.
+ Responsible for the final review of department submissions and provide technical input for Quality Overall Summaries, Pharmaceutical Development Reports and other supporting technical documents, and present regulatory strategy.
+ Assist with the final review of other department submissions, as well as with decision making on complex CMC issues.
Communication & Collaboration
+ Communicate with R&D Formulations, Technical Operations, Analytical R&D, Manufacturing, Quality Control, Quality Assurance and Par’s internal audit group throughout the development and submission process to ensure all submission related documents (batch manufacturing and control records, packaging records and analytical reports) are assembled and reviewed on an ongoing basis, with problems identified and addressed concurrently.
+ Communicate and effectively follow-up with the FDA on various regulatory issues.
+ Interact and communicate with Project Management on submission and project time lines.
+ Serve as regulatory representative to assigned Project Teams and interact with corporate partners in order to achieve common goals.
+ Review internal and external change requests as well as associated documentation and provide effective regulatory strategy to support change which is in compliance with 21 CFR 314.70.
+ Utilize and remain current with internal/external electronic submission initiatives.
+ Prepare and/or review of new and revised departmental Standard Operating Procedures.
+ Prioritize work flow to maximize efficiency.
+ Participate and represent department at project meetings.
Regulatory databases and FDA Guidance
+ Ensure that the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and USPTO databases are monitored on a regular basis for updated patent and exclusivity information that may affect potential or pending ANDA products.
+ Monitor FDA CDERNEWS and applicable web sites for new Orange Book listings, competitor Paragraph IV Certifications/Approvals and New Guidance, labeling updates that may impact pending/future ANDAs and provide impact on project/company.
Business Development Support
+ Interface with internal/external legal counsel and Business Development on patent infringement issues, paragraph IV certifications and notices to patent holders.
+ Conduct regulatory review of innovator products, associated patent and exclusivity status, including pediatric extensions for new product submissions.
+ Conduct regulatory due diligence for internal and/or external R&D projects.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
+ Bachelor’s degree in a scientific or other related discipline or an equivalent overall level of knowledge based upon previous work experience.
+ 10-12 years’ experience in Regulatory Affairs.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
+ Knowledge of government regulations, policies and procedures and current Good Manufacturing Practices
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
+ Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
+ Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Establishes goals and objectives which are consistent with department and company objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
+ Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
+ Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
+ Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
+ Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self-available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
+ Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
+ Delegation - Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results.
+ Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
+ Office required due to confidential nature of work.
+ Limited overnight travel may be required.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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Endo Job Description Template - Revised July 2014