Senior Manager CMC-RA
Astellas Pharma Europe B.V. - Leiden (Nederland)
For our client, Astellas Pharma Europe B.V., we are looking for a Senior Manager CMC-RA.
As Senior Manager CMC-RA, you play a key role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. You are responsible for the development and successful execution of CMC regulatory strategy (e.g., CMC strategy/planning for NMEs and NBEs) in close collaboration with Global Regulatory Lead, and writing of CMC documents (e.g., CMC modules, IND/IMPD CMC documentation). You can act as the subject matter expert (SME) for Regulatory CMC and work in close collaboration with stake holders (e.g., Pharmaceutical Technology including PPM and Manufacturing, Quality Assurance, Business Partners).
- Independently act as CMC regulatory lead or Deputy for complex projects/ products and/or participate in non-product or overarching related activities;
- Prepare and review with minimal supervision, CMC documentation of e-CTD Quality modules, IND/ CTA /IB and briefing documents for Health Authority (HA) consultation meeting for assigned products;
- Act as CMC regulatory expert by global project and product teams/task forces and is accountable for recommending global CMC regulatory strategy. Work closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stake holders to ensure consistency and to identify options for risk discussions;
- Member of global project teams/task forces which require expert interpretation of applicable EMA/FDA /PMDA /ICH/Global regulations to ensure CMC compliance within the organisation;
- Provide CMC regulatory expertise for New Product Planning and Licensing due diligence activities;
- Manage the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with local and global stake holders, determine the best way to present information in assigned regulatory submissions to maximize reviewability by global Health Authorities;
- Prepare and review summary tables of data from research and manufacturing reports;
- Define and implement regulatory strategies and priorities for; global and regional registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control processes and related compliance issues in collaboration with local , regional and global stake holders;
- Oversee submissions and ensure that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Review regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and registration filings and DMFs;
- Actively seek out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporate this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stake holders for chemistry, manufacturing and controls aspects;
- Provide regulatory guidance for compendial issues of Ph.Eur., USP and JP and monograph preparation.
You interact with management level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. SME role in health authority meetings. Work on complex and diverse problems with suggestion as SME that has functional or corporate impact.
Who we're looking for
The ideal candidate has a B.Sc./M.Sc. or Ph.D. in Chemistry/Pharmaceutics with several years of experience in Regulatory Affairs or in a CMC regulatory role. You have experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope. Other requirements are:
- Experience with process development, analytical characterisation, process scale - up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms);
- Demonstrated track record for successful interactions with (global) health authorities related to CMC submissions;
- Effective writing skills with the ability to meet regulatory requirements and standards;
- Ability to understand regulatory environment and apply concepts to perform job function ;
- Advanced, interpersonal written and oral communication skills; advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast - paced environment; able to manage complex projects by exercising independent decision making and analytical thinking skills;
- Knowledge/experience of EU, US and/or Japan regulations, guidelines and regulatory processes for NCEs , NBEs and product life cycle maintenance;
- Ability to work in cross - functional and international environment;
- Detail - and goal - oriented, quality conscientious, and customer - focused;
- Ability to adhere to strict project timelines;
- Strong team player;
- Good judgement and problem solving skills, with ability to identify, analyse, and resolve problems in a timely manner.
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people world-wide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people world-wide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Education||:||HBO/BSc. WO/MSc. PhD.|
|Employment terms||:||Salary: >4500|
Days of leave: 25 + 13
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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