Regulatory Affairs US Labelling Strategist (Snr Mgr or Associate Director) - Strategic Labelling Role! (Code USA 060121)

Reference: TM060121A

Expiry Date: 06-06-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Wake County
United States

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Job Description

Regulatory Affairs US Labelling Strategist (Snr Mgr or Associate Director) - Strategic Labelling Role!

We have a great opportunity for a Regulatory Affairs Labelling specialist to move into an exciting and expansive strategic labelling role covering both development and lifecycle products. 

Locations are varied, and this role can be covered from Atlanta, Georgia or RTP, North Carolina or Cambridge, Massachusetts with options also available for home working.

You will own the development, review, approval, and maintenance of labeling for designated products and lead the Cross Functional Labeling Team, managing major US labeling projects & initiatives. You will also be participating in the development of the labeling objectives early in product development to assist teams in creating development strategies and working in conjunction with regional leads, representing regional and local perspective during the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS).

My client is passionate about science and innovation, and they are looking for passion and innovation in their regulatory leadership positions as well.  They have a strong pipeline and a good number of new innovative product launches planned over the next 3-5 years and are also involved in developing Gene Therapy products, so it’s an exciting time to join as the future looks extremely positive. As well, they have a number of global blockbuster (marketed) products in both Immunology and Neurology across both small and lager molecules.

Ideal candidates will have extensive regulatory labelling experience coupled with a proven track record of strategic agility and proven experience with engagement and relationship building within your current organisation. You will also need excellent communication and influencing skills plus proven experience with line management with a Life Sciences degree or equivalent.

Responsibilities:

  • Provides strategic labeling support to drug development teams
  • Leads labeling sub-teams in developing labels for new products in Immunology to safeguard regulatory compliance
  • Manages the revision, review, approval and distribution of Developmental Core Data Sheets, Company Core Data Sheets, US Package Inserts
  • Lead complex labeling discussions with cross-functional labeling teams driving consensus through strategic thinking and collaboration
  • Adhere to operational quality/compliance standards throughout labeling processes
  • Collaborate with country-level Regulatory Affairs to ensure understanding of strategic and regulatory labeling issues
  • Support assessment and implementation of new/revised company procedures and Health Authority labeling guidance/regulations
  • Collaborate with both new and experienced colleagues to foster a supportive environment and continuous learning.

Qualifications needed:

  • Biotech or pharma regulatory labeling experience is required: with 4+ years of experience at the Manager level
  • In-depth knowledge of the labeling process, industry practice, packaging manufacturing process, and the drug development process.

 

To Apply!

If you are interested in applying for this role or wish to call me to discuss the role in more details please call (Theo Moore) on 855 505 1382 or email me via Theo@AdvTalent.com. Alternatively,  please press the red “Apply for position” button and follow the registration process.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number 855.505.1382.

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