Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit http://www.covidien.com to learn more about our business.
Founded as Mallinckrodt in 1867, the $2 billion Covidien pharmaceutical segment is in the process of spinning off into a separate business. This creates exciting opportunities to grow your career within an established organization that is soon to be an independent public company. Currently, the Company expects that the spinoff process will be completed in mid-2013. While we are undergoing the process, the pharmaceuticals business remains a segment of Covidien, and will continue to operate according to the Company’s strategic plan, focusing on our customers and patients who rely on our products. Equally important, pharmaceuticals’ mission remains the same: To make diagnostics and medicines better and safer for you and your family.
SUMMARY OF POSITION :
The Senior Regulatory Affairs Specialist-Generalist responsibilities encompass the support of worldwide product registrations and support of Regulatory activities including but not limited to:
- Prepares, submits and maintains regulatory filings with relevant health authorities.
- Prepares, submits and maintains product specific dossiers per local country requirements
- Participates in new product development core teams and creating of Regulatory Strategies
- Maintains country specific site registration requirements
- Under limited direction, prepares documentation for product incident reporting as required.
- Reviews product labeling as required
- Under limited direction, reviews advertising and promotional material as required
- Maintains regulatory knowledge of current guidelines and regulations
- Maintains current regulatory knowledge by attendance at regulatory seminars and meetings
- Maintains current regulatory databases and produce various reports as needed
- Utilize and support electronic document management system
- Responds to inquiries from health authorities.
- Reviews and assesses regulatory impact associated with changes made at the manufacturing facilities for multiple regions.
- Provides training and support to colleagues as needed
ESSENTIAL FUNCTIONS :
- Organization and preparation of final regulatory filings (e.g. product submissions and site/establishment registrations)
- Reviews change control documents and assess regulatory impact
- Obtaining/maintaining Certificates of Pharmaceutical Product (CPP)
- Requesting and routing registration fees to appropriate parties
- Collaborate with internal Covidien departments to obtain and understand registration documents
- Collaborates with Covidien Regulatory Personnel in multiple functional areas and regions to communicate change and discuss regulatory strategy.
- Establishes and maintains a professional and credible image with regulatory agencies
- Understands and recommends strategies based on current local registration requirements and applicable industry standards
- Understands local country quality requirements (e.g. cGMP, ICH)
- Manages multiple, priorities
- Responds to inquiries from health authorities
- Participates in new product development core teams and create Regulatory Strategies
- Mentor less senior colleagues as well as provide training and support.
- Attends necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession.
- Processes, interprets and provides recommendations for complex, unusual issues.
- Critically reviews documentation for regulatory submissions and provide input for necessary revisions.
- Prepare Global PSURs as required by relevant Health Authorities
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS :
Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS :
preferred: Bachelor’s Degree required, preferably in scientific or related discipline.
Experience : A minimum of 5 years experience required in Regulatory Affairs or related field. RAC certification preferred.
Experience in managing submission compilation and cross functional review required.
Experience with ASEAN and/or Latin America Pharmaceutical Drug regulations.
Demonstrated knowledge of ICH and GMP requirements.
Demonstrated ability to manage and track deliverables
Ability to facilitate decision making
Preferred Regional Asia Pacific and/or Latin America
- Strong organizational skills
- Ability to prioritize
- Ability to problem solve
- Ability to work well with others
- Team oriented
- Strong background using Microsoft Office tools and Adobe Acrobat
- Excellent written and oral communication skills
- Ability to facilitate decision making on specific content where expertise may reside with team members.
- Strong evidence and mastery of being Team Contributor.
- Attention to detail and overall drug application quality and internal consistency.
- Strong Decision Making Skills
- Ability to operate independently under limited supervision.
- Strong interpersonal, and negotiation skills, conflict management, priority setting, strategic agility, building effective teams, managing vision and purpose.
ORGANIZATIONAL RELATIONSHIPS/SCOPE :
The Sr. RA Specialist reports to a Regulatory Affairs (RA) Manager and will interact with other departments throughout the organization.
Normal office environment. Travel Time Required - up to 10% (May vary depending on region/site)
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
As a global healthcare leader, we drive advances in medical devices and medical supplies. Thanks to our scale, scope and pioneering spirit,...