Senior Manager - Labelling Strategist

Kindly forward your CV in English to [email protected]

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.

We are seeking an experienced Senior Manager – Labelling Strategist to support a project in London. Our ideal candidate is a versatile engineering professional, with superior skills and experience in the optimization of procedure improvement and a willingness to work in a dynamic, on-site pharmaceutical project environment.

Responsibilities:

• Create, prepare, and revise CCDS, US and EU labeling for mature and life cycle products assigned to obtain company and/or agency approval.
• Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling 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 labeling 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 labeling implementation and the dynamics of Labeling Team purpose and objectives.
• Knowledge of the principles and concepts of Labeling, 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 labeling strategy.
• Strong ability to lead meetings and propose labeling strategy, working well in cross-functional teams, and able to negotiate, resolve conflict and build consensus.
• Lead a multidisciplinary labeling working group and provide labeling 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 labeling topics.
• Must be able to construct a Company Response (MAH response) for health authority questions related to labeling.
• 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 labeling team on EU regulations.

Requirements:

• Bachelor’s degree in scientific discipline background, or relevant/equivalent experience within Regulatory Affairs and Labelling fields, or with equivalent experience in highly regulated environment.
• Mandatory Knowledge of relevant and applicable London / EU regulations.
• Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
• Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance.
• Adjusts behaviors to drive high quality deliverables.
• Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.
• Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
• Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.
• Enthusiasm & confidence.
• Adhere to our principles and values.
• Time Management skills.

Why PharmEng Technology?

Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.

What We offer:

• Comprehensive benefits package & competitive wages.
• A supportive environment where employee growth is promoted.
• Paid holidays.
• Other great incentives.

EEOC Statement:

At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.

Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.