RA manager, TW&HK

About Convatec

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

Our search for better is changing the lives of our patients. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We're looking for a motivated and passionate individual to join our team as Regulatory Affairs Manager , to have real impact and bring Forever Caring to life.

About Role

In this role, you'll play a key part in working alongside a dynamic team that values innovation, collaboration, and continuous growth. Your key responsibilities will include:
•Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports
•Providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies
•Interacting and negotiating with regulatory agency personnel in order to expedite approval of pending registration and answer any questions
•Serving as a regulatory liaison on the project team throughout the product lifecycle
•Participating in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan, chemistry manufacturing control (CMC)
•Ensuring pre-clinical and clinical trial designs meet regulatory requirements
•Ensuring rapid and timely approval of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices
•Serving as regulatory representative to marketing or research project teams and government regulatory agencies
•Providing advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations
•Coordinating, reviewing and potentially preparing reports for submission In some organizations, may coordinate and maintain reporting schedules for new drugs, medical devices, and biologic/biotechnology and marketed products notices.

About You

To be successful you will:
• Managing projects / processes, working independently with limited supervision.
• Coaching and reviewing the work of lower level professionals.
• Problems faced are difficult and sometimes complex.

Education/Qualifications

• Minimum educational requirements if applicable (for example Degree, industry qualifications, etc)

• Industry memberships / Professional Registrations

What You’ll Get

At Convatec we believe in taking care of our people, because they’re the heart of everything we do. As part of our team, you’ll enjoy a range of benefits designed to support your wellbeing, growth, and success.

These include

• Flexible working arrangements,

• Ongoing learning and development opportunities

• Competitive remuneration

• Access to health and wellbeing programs

Ready to join us?

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

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Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!