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EU/EEMEA Regional Regulatory CMC Leads Associate Director Hoddesdon United Kingdom,
Posted on : 15 May 2017
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- EU/EEMEA Regional Regulatory CMC Leads develop and execute EU/EEMEA regional CMC strategy for pipeline and marketed vaccines and biotechnology products.
- Today, our company has more than 50 prescription products in various therapeutic areas, such as cardiovascular disease, respiratory disease, oncology, neuroscience, infectious diseases, immunology and women's health.
- Vaccines are one of the greatest public health stories in history.
- Our company and its legacy companies have been discovering and developing vaccines for more than a century.
- Our unique vaccines have helped prevent a number of diseases, including ones never thought preventable.
- Today, we remain dedicated to the complex business of researching and producing vaccines and biotech/biotechnology products.
- Our marketed product portfolio and pipeline is diverse including small and large molecules, vaccines, a variety of dosage forms and drug-device combination products which offer exciting opportunities and challenges for regulatory CMC professionals.
- These key positions will be part of a new RA CMC Regional Center of Excellence based in the UK which is a key component of our company s strategy to build strong and proactive relationships with EU/EEMEA Regulatory Agencies and to develop innovative, robust regional CMC strategies.
- The regional team will ensure communication and alignment of the regional strategy with global CMC strategy by developing strong partnerships with Global CMC Product Leads, company Country RA Affiliates, Regional Commercial and Operations (supply chain) and the Quality organisation to enable high quality right first time submissions, successful launches and reliable patient supplies throughout the product life-cycle.
- Each team member will manage a portfolio of products and will adopt a lessons learnt approach to build a center of excellence for regional EU/EEMEA submissions.
- All candidates will have a sound knowledge and direct regulatory experience of EU and/or at least one sub-region of the EE/ME/A countries and be aware of current regulatory policy hot topics relevant to the development, registration or maintenance of vaccines or biologic/biotechnology products in regional markets.
- Candidates may be required to travel to other company sites.
- For assigned product portfolio, EU/EEMEA RA CMC Leads will have primary responsibility to develop robust CMC regional regulatory strategies for new marketing applications, Scientific Advice and post-approval changes.
- Working collaboratively with Global CMC RA Product Leads, the Regional RA CMC Leads will ensure right first time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the lifecycle.
- Ensure that the regional CMC regulatory strategy is aligned with the global regulatory strategy, Therapeutic Area portfolio, commercial and operational strategies and the Target Product Profile issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.
- Support company Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of submissions (as CMC content subject matter expert). Director/Associate Director roles will have direct interaction with Health Authorities. Subject Matter Expert - SME).
- Act as Regulatory CMC SME in post approval requirements and maintain/update the regulatory intelligence repository for Regional markets including communicating proactively with Global CMC Product Leads on regional registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to support right first time submissions.
- Ensure high quality and timely responses to Regulatory Agency questions in Regional markets and fulfillment of regulatory commitments to Regulatory Agency deadlines.
- Support product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.
- Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.
- Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business.
- Bachelor s or Master s Degree in a chemistry, pharmacy, biology or related science.
- At least five (5) years of relevant regulatory CMC experience (covering at least one sub-region of the EU/EE/ME/A countries) for Senior Specialist, at least seven (7) for Associate Director and at least 10 years for Director positions. Senior positions are likely to also have additional prior experience in the pharmaceutical/device industry including manufacturing, testing, research; or licensure of products.
- Direct regulatory CMC experience in development and registration of biologic/biotechnology products or vaccines is required for Director and Associate Director positions. Direct Health Authority experience would be an advantage.
- Some Associate Director/Director roles may require management responsibility for a small team of Regulatory (Senior) Specialists.
- Knowledge of current ICH and local Regulatory Agency legislation and guidance and current hot topics related to pharmaceutical, biological and/or vaccine products.
- Ability to communicate effectively in English (written and verbally proficient).
- Ability to influence and a keen eye for detail.
- Ability to work well under pressure either independently or collaboratively in a team.
- Additional qualifications such as PhD degree and language skills are an advantage.
- Our employees are the key to our company s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Travel: Yes, 20 % of the Time
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