Director Regulatory Affairs CMC
Director Regulatory Affairs CMC
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Job Description
The Director Regulatory Affairs CMC will be responsible for the development strategy and tracking of CMC regulatory activities for assigned BicycleTx programs or projects.
The Director Regulatory Affairs CMC will be responsible for supporting the delivery of CMC regulatory strategy and submissions for their assigned BicycleTx programs or projects working closely with crossfunctional colleagues and the Senior Director Regulatory Affairs CMC. As an integral member of the team that will be tasked with CMC product development the Director Regulatory Affairs CMC will also serve as a subject matter expert (SME) for assigned activities which may involve multiple partners and collaborators and will ensure adherence to relevant regulatory requirements.
- Responsible for the development and of global regulatory CMC strategy and submissions for assigned BicycleTx programs or projects including CMC dossiers to support clinical trial applications
- Responsible for the regulatory assessment of change controls maintenance of regulatory files and tracking databases related to CMC submissions
- Collaborate with internal colleagues and external organizations to develop submission content plans and timelines and support the timely of regulatory submissions that require CMC content authoring of responses to questions audits and inspections
- Manage the preparation drafting review risk analysis and mitigation planning of CMC submissions (e.g. Module 3 IND IMPD amendments and annual reports) for assigned BicycleTx programs or projects
- Developing and maintaining internal crossfunctional relationships to support the development and of CMC regulatory submissions for assigned BicycleTx programs or projects
- May act as the Global/Regional CMC Regulatory Lead for assigned development programs
- May support preparations and attend regulatory authority meetings for assigned development programs
- Support the development of processes SOPs and other controlled documents including for Regulatory Affairs activities
- Monitor the CMC regulatory landscape e.g. views of HAs regulatory precedents labeling differences and other CMCspecific issues to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects
- Accountable for maintaining working knowledge of CMC laws guidances and requirements relevant to assigned BicycleTx programs or projects in addition to general regulatory knowledge
Qualifications :
- Bachelors degree in a scientific field or postgraduate degree preferred
- Extensive experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry; particularly relating to peptides drugconjugates and/or radiopharmaceuticals; any indepth experience may be limited to one specific region (e.g. US or EU)
- Working knowledge of FDA EMA ICH and cGMP CMC regulatory guidance and regulations
- Experience and knowledge in preparation of CMC sections of INDs CTAs NDAs MAAs or regional equivalents is required
- Experience and knowledge in the supportive interactions with health authorities including US FDA EMA and/or EU Member States is desirable
- Ability to communicate on topics of basic science is essential; an understanding of the drug product lifecycle from discovery to clinical trials to marketing is required
- Ability to proactively identify risks and develop risk mitigation strategies
- Adaptable with the ability to generate creative solutions identify different and novel ways to find solutions and adapt to changing priorities and deadlines.
- Highly collaborative strong relationship building skills with internal and external partners with a high level of integrity
- Works proactively using solid communication and influencing skills to effectively execute program goals for assigned BicycleTx programs or projects
- Works effectively in a highly complex and fastpaced environment
- Strong organizational and time management skills
- Position may require some domestic and international travel
Additional Information :
- Flexible working environment
- Competitive reward including annual company bonus
- Medical dental and vision insurance for eligible employees and their families with 100 of the premiums covered by the Company
- Health and Dependent Care Flexible Spending Accounts
- 401(k) plan with a 4 Company match and immediate vesting
- Eligibility to accrue up to 23 paid time off days per full year worked plus the option to buy up to 5 additional days
- Employee assistance program
- Employee recognition schemes
- 10 Company holidays
- Competitive Family Leave Policy
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore all qualified applicants will be considered for employment and we do not discriminate on the basis of race religion colour gender sexual orientation age disability status marital status or veteran status.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
