Regulatory Associate Director, Labelling
A leading pharmaceutical company is currently recruiting for a Regulatory Associate Director to join their team at their Hertfordshire office. The company is one of the industry's most well-known brands and specialises in R&D in 3 major areas; respiratory, oncology and inflammation.
- Providing global strategy and labelling leadership for development assets and oversight for established products.
- Driving optimal regulatory labelling outcomes for development assets across development and life cycle management to deliver technical excellence enabling R&D and commercial success.
- Driving optimal product labelling approaches that facilitate the safe and accurate use of company products and enables product/portfolio differentiation and competitiveness.
- Ensuring ongoing compliance of established products in the life cycle process via our outsourcing partners.
- Leading initiatives within regulatory and in partnership with other functions (artwork, IACs, drug safety etc) to improve labelling process and compliance.
- Providing overall strategic labelling expertise and leadership across all products.
- Working with regulatory leads and wider teams to define strategies to gain optimised labelling for development products.
- Engaging with regulatory leads to input labelling viewpoint into effective agency negotiations and interactions.
- Strategically directing outsourcing partners to ensure effective delivery of labelling support for our established product that is fit for purpose and aligned with objectives.
- Undertaking labelling Due Diligence review supporting where required.
Skills and Requirements:
- Ability to work within the regulatory team and wider asset teams to influence and advise on labelling strategy and issues.
- A global mindset that seeks alignment across regions with a pragmatic approach.
- Comprehensive knowledge of relevant legislation and guidelines and ability to communicate these concepts across multiple levels of the organisation.
- Willingness to take ownership and drive through change and strategies.
- Taking ownership, identifying solutions, proactively drives improvements, making decisions, delivering on promises and learning from all experiences.
- Using a growth mind-set with the desire to think differently, push boundaries, be innovative and is curious to learn.
- Working in a collaborative approach to contribute to both team and business success with a "win as one" mind-set.
- Understanding and meeting customer needs, taking pride in both our work and how we deliver. Demonstrating excellence in all that we do.
- Giving clear direction for the vision and strategy, defines, plans, communicated priorities and sets expectations.
- Understanding marked and customer dynamics. Anticipates and makes case for change Influences and mobilises others, uses feedback to drive accountability and change.
- Ability to see, enable and connect people and business opportunities to support growth Builds a constructive feedback loop between customers, partners and employees.
- Promoting a culture of empowerment and trust through high challenge and high support, fostering a "fail fast and learn" attitude. Lighting the fire in people, not under team.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at 0203 761 5702 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Up to £95000.00 per annum
A leading biotechnology company is seeking to recruit a Regulatory Affairs Director, CMC Biologics to their office in London.
A global top 10 pharmaceutical company has an exciting Head of Regulatory Affairs position available at their site in Berkshire.