Regulatory Affairs Specialist
The Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies and programs pertaining to development and marketing of drug and/or biological products. This role includes the lead regulatory responsibility for support of global registration and life cycle support, and includes the leadership of regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.) coordinating support via a Global Regulatory Strategy Team composed of core regulatory support functions.
Works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables.
Global regulatory strategy and implementation; personnel hiring and deployment decisions as well as their supervision; budget input; defining strategic priorities.
Represents the organizational unit as prime internal and external contact on contracts or operations. Interacts with equivalent level managers concerning matters of significance to the company. Conduct briefings / meetings for top management.
Strong interaction with leadership in global regulatory affairs and development functions and senior business unit leadership.
Likely to involve some domestic and international travel.
location: Cambridge, Massachusetts
job type: Contract
salary: $88 - 103 per hour
work hours: 9 to 5
25% - Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations. Single point of contact and accountability for regulatory and leads the regulatory subteams as well as represents regulatory on key internal decision making teams such as PSTs and GDTs.
25% - Functions as the global regulatory lead for assigned projects, working with a cross-departmental group of regulators as part of Global Regulatory Team, including CMC, Operations, Labeling, International, Advertising/Promotion and Intel/Policy to drive global regulatory strategies.
- Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with product development for assigned projects.
25% - Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
5% - Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
- Effectively leads key meetings with HAs to ensure full discussion of issues and opportunities.
5% - Provides guidance to all appropriate departments in Shire to assure compliance with applicable regulations.
- Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel as appropriate
- Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
5% - Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to Shire staff.
5% - Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
5% - May supervise a changing number of Regulatory Affairs Associates.
- Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to Shire staff.
- BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
- Generally has at least 8-15 years of Regulatory Affairs experience, including equivalent experience in the biopharmaceutical industry. The regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as the US, EU, Japan and Canada) to ensure appropriate leadership and mentoring for regulatory staff within Shire.
- 2-5 years of management experience preferred
- Demonstrated ability to routinely accept empowerment from senior leadership to proactively resolve issues and identify and champion opportunities toward optimal regulatory strategies and implementation.
- Works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables.
- Develops corporate and/or organizational policies and authorizes the implementation of these policies.
- Responsible for the successful operation of activities of major significance to the organization.
- Represents the organizational unit as prime internal and external contact for GRA
- Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s), supported by the local staff.
- Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
- Experienced in responding to inquiries or complaints from HAs.
- Ability to present complex issues in oral and written form.
- Proven ability to work successfully with cross-functional teams and influence appropriate plans and actions.
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
- Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
- Excellent interpersonal, communication, analytical, managerial, and organizational skills.
- Ability to effectively present information to senior management, public groups, and other departments.
- Demonstrated ability to motivate, mentor and manage a team.
- Consistently demonstrates and models Shire core values.
skills: CMC, Regulatory Affairs Strategy, Submissions, AMCP
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.