Needed==Senior Labelling Strategist, Remote (need candidates from EST time zone)

Hi,

Pleasure mailing you. Please go through the below requirement and let me know if you are comfortable for the position.

Please send me your updated resume along with the best hourly rate, work authorization status and availability. An early response is really appreciated.

Job Title: Senior Labelling Strategist

Location: Remote (need candidates from EST time zone)

Duration: 12+ Months

Responsibilities

Create, prepare, and revise CCDS, US and EU labelling for mature and life cycle products assigned to obtain company and/or agency approval.
Coordination of labelling review and approval throughout the E2E labelling process, which includes preparation of labelling components for submission to regulatory agencies, participation in labelling negotiations with agencies resulting in product approvals or labelling updates, and release of labelling for use throughout the company.
Strong knowledge and experience of Rx to OTC switch requirements.
Provides oversight for team and provides strategic guidance on complex labelling projects.
Must be able to work with all levels of associates and direct management within the Company (domestic/international) and demonstrate good communication, interpersonal and organizational skills.
Anticipates any hurdles in implementation and acts to minimize them.
Demonstrated knowledge and understanding of regulatory requirements for the CCDS, US and EU and local labelling implementation and the dynamics of Labelling Team purpose and objectives.
Knowledge of the principles and concepts of Labelling, including generics, authorized generics, private labels, device/combination products
Ability to read and interpret HA regulations and guidance, and underlying SOPs
Proven ability to lead regulatory strategy into labelling strategy.
Strong ability to lead meetings and propose labelling strategy, working well in cross-functional teams, and able to negotiate, resolve conflict and build consensus.
Lead a multidisciplinary labelling working group and provide labelling strategy proposal (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, preclinical and CMC…)
Proficient in presenting to senior management when required.
Highly detail oriented, strong analytical and organized skills, project management skills, self-starter, leadership skills, critical thinking required, strong ability to network and coordinate discussions across all levels of the company to reach resolution on labelling topics.
Must be able to construct a Company Response (MAH response) for health authority questions related to labelling.
Be an active member of Response Teams within procedures such as European Arbitration/referrals, or work-sharing, PRAC questions (signal detection…)
Extensive knowledge of EU regulations; be up to date with EU guidance’s/regulations and inform management and team of changes.
Provide periodic training to the labelling team on EU regulations.

Qualifications we seek in you!

Bachelor’s degree, in scientific discipline, or relevant/equivalent with relevant years of experience in Regulatory Affairs Labelling or equivalent in highly regulated environment.

Thanks,