Regulatory Affairs Associate Director, CMC

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.

PRIMARY JOB FUNCTION:
As an individual contributor, the function of a CMC Regulatory Affairs Associate Director is to combine knowledge of scientific, regulatory and business issues to ensure products developed, manufactured and distributed to meet regulations.  The individual has department level influence and is generally recognized as an expert resource both within AbbVie and externally.  The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory updates.  The individual will work with CMC product teams to ensure that data are identified, obtained and effectively presented for the registration of products worldwide.

CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Core job responsibilities for this function may include:

Strategic Planning:
· Identify need for new regulatory policies, processes and SOPs and approve them
· Provide strategic guidance for product development and planning throughout the product lifecycle
· Develop global CMC regulatory strategies and update based upon regulatory changes
· Monitor emerging issues and identify solutions
· Monitor trade association positions for impact on company products
· Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams

Premarket:
· Approve CMC regulatory filing strategies based upon proposed preclinical, clinical and manufacturing plans

· Monitor impact of changing regulations on CMC submission strategies and update internal stakeholders
· Communicate application progress to internal stakeholders
· Monitor and submit applicable reports and responses to regulatory authorities
· Negotiate with regulatory authorities during the development and review process to ensure submission approval
· Provide strategic input and technical guidance on CMC regulatory requirements to development teams
· Deliver CMC regulatory dossiers to support clinical studies

· Formulate company responses to regulatory authority queries on CMC submissions

Postmarket:
· Oversee processes involved with maintaining annual licenses, registrations, listings and patent information for CMC
· Ensure compliance with product postmarketing approval requirements
· Review and approve required reports, supplemental submissions and other postmarketing commitments
· Review potential CMC changes for level of change and consequent regulatory notification, deliver required regulatory dossier to enalbe changes

· Identify and present option for risk mitigation to decision makers

Job specific responsibilities may include (choose applicable areas and expand as appropriate);
· Compendial / standards
· Import / export
· Country specific regulatory support

COMMENTS:
Individual provides leadership without direct authority (i.e., project leader).  Individual may provide direction and guidance to exempt, non-exempt and/or supervisory personnel who exercise significant latitude and independence in their assignments.  Also may mentor other department members.

POSITION ACCOUNTABILITY / SCOPE:
Scope is division-wide regulatory direction for product development and support to develop most rapid successful strategy for approval to market products to meet business objectives; administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions for on market products.  Must assure that all deadlines are met and provide effective leadership without direct authority.  Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments.  Completed work is reviewed from a relatively long- term perspective for desired results.  Individual is recognized as an industry expert and resource in regulatory affairs.

Influence/Leadership:
· Develops, communicates, and builds consensus for operating goals that are in alignment with the business.
· Provides leadership by communicating and providing guidance towards achieving department objectives.
· Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units.
· May lead a project team or initiative within department or cross-functions.

· Provides technical leadership to business units.
· Acts as a mentor to less-experienced staff.
· Exercises judgment independently.

Planning/Organization:
· Creates immediate to long-range plans to carry out objectives established by top management.
· Forecasts project related needs including human and material resources and capital expenditures.

Decision Making/Impact: 
· Assignments are expressed in the form of objectives
· Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
· Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.  M.S. in a technical area or M.B.A. is preferred. 

5-7 years experience in a regulated industry (e.g., medical products, nutritionals). 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Note: Higher education may compensate for years of experience.

Preferred Qualifications:

- Experience with CMC related activities is preferred.

- Experience with medical devices or combination products may be useful .

Background / Skills / Knowledge
Regulatory Knowledge of (as applicable):
· Regulatory history, guidelines, policies, standards, practices, requirements and precedents
· Regulatory agency structure, processes and key personnel
· Principles and requirements of applicable product laws
· Submission/registration types and requirements
· GxPs (GLPs, GMPs)
· Domestic and international regulatory guidelines, policies and regulations
· Ethical guidelines of the regulatory profession, and regulatory process

Technical/Business Ability to:
· Monitor external environment in area of technical or professional responsibility

Communication Skills or Ability to:
· Communicate effectively verbally and in writing
· Communicate with diverse audiences and personnel
· Work with cross-functional teams
· Work with people from various disciplines and cultures
· Write and edit technical documents
· Prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies
· Negotiate internally and externally with regulatory agencies

· Plan and conduct meetings
· Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks

Cognitive Skills or Ability to:
· Pay strong attention to detail

- Assess manufacturing and analytical processes for regulatory implications
· Manage projects
· Create project plans and timelines
· Manage multiple and competing priorities
· Think analytically with good problem solving skills
· Organize and track complex information
· Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
· Exercise good and ethical judgment within policy and regulations
· Use in-depth knowledge of business functions and cross group dependencies/ relationships
· Define regulatory strategy
· Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
· Perform risk assessment or analysis
· Investigate and solve problems that impact work processes and personnel within or across units or departments
· Lead functional groups in the development of relevant data to complete a regulatory submission

- This position could also be filled at a Project Manager level depending on qualifications.