J&J Family of Companies EMEA RMC Submission Management Lead in Poland
Janssen, part of Johnson & Johnson Family of Companies, is now looking for an experienced EMEA RMC Submission Management Lead:
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.
EMEA RMC SUBMISSION MANAGEMENT LEAD
Location: anywhere within EMEA region
Full time permanent contract
The Regulatory Management Centre is a new regional regulatory organization to handle the majority of LOC activities in the area of tactical lifecycle management processes like CMC and Labelling variations.
The Centre is embedded in the AP, EMEA and LA regional organizations, and it will work in close collaboration with the respective LOCs, regional and global teams.
The EMEA RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports) and LOC team members (matrix organization).
This is a new position in EMEA Regulatory Affairs that is envisaged to support a large, diverse and complex geographic region. The responsibility of ERMC Submission Management Lead is to:
lead a wide range submission processes for multiple countries, preparing country-specific submission ready dossiers, manage Health Authorities questions when required and ensure post-approval activities to take place for those submissions.
lead the Submission Management team
Lead the Submission Management team and act as a primary contact between the RMC Head, RMC Planning Lead and Submission Management team members
Go-to person for Submission Management team on content, process and LOC interaction
Lead and facilitate LOC CMC/ label variation processes from global dispatch to kick-off of local implementation following RMC processes
Prepare submission strategy based on global dispatch and country specifics
In collaboration with LOC staff, prepare submission-ready dossier based on local regulations and country specific requirements covered in “recipe book”
Assess and implement label changes
Involve and follow-up with others responsible for specific process steps, eg. for data management or translations
A minimum of a University degree or equivalent by experience
At least 7 years of regulatory experience
The following experience would be an asset: in people leading, in a virtual team and/or local affiliate organization would be of advantage
Experience in regulatory submission management in co-operation with HAs.
In depth knowledge of local and regional regulations/legislation
Experience in working with limited supervision and able to make independent decisions
Excellent verbal and written communication skills
Proficiency in written and oral English
Cultural sensitivity and ability to work and thrive in a multi-cultural environment.
Proactive team player, able to take charge and follow through.
Achievement - oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
Proficient use of technology including RA tracking systems – preferred
The position is in a LOC or a TA-hub in the EMEA region. No relocation is required
Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones and be reachable in case of emergencies
Occasional international travel (2-4/year) may be required.
Unique opportunity to become part of a global pharmaceutical market leader
Versatile and fulfilling role in a dynamic environment
Senior position in a complex structure of an international corporation
Work in a supportive and highly professional team
Further opportunities for professional development and career growth
Motivating financial remuneration and further employee benefits
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English.
Janssen Biologics (7266)