Director, CMC Regulatory Affairs
Viking Therapeutics, Inc., San Diego, California, United States, 92189
Description
The Director, Regulatory Affairs CMC (RA CMC) will provide Regulatory Affairs CMC leadership for development teams throughout the development program (discovery, development, submission, approval and post-approval) of Viking Therapeutic’s candidate projects. The Director RA CMC will be responsible for the development of efficient and effective CMC regulatory strategies and in the implementation of those strategies to achieve commercial status and lifecycle success.
Essential Duties and Responsibilities The main Regulatory Affairs responsibilities of this role include but are not limited to the following:
Develop regulatory intelligence as the basis for the formulation of efficient and effective CMC regulatory strategies with international scope
Implement developed regulatory strategies
Identify and implement tactics and positioning with other stakeholders (internal and external) to achieve the earliest possible approvals of all regulatory submissions
Represent the company as the primary regulatory CMC expert in corporate alliance team structures to facilitate the attainment of the corporate alliance objectives
Interact and negotiate with domestic and foreign regulatory agencies as the primary responsible party
Coordinate, draft, prepare and submit regulatory applications and documents
Take lead role in management of regulatory CMC activities for key projects and coordinate filing efforts between corporate disciplines
Identify and define key regulatory issues related to the manufacturing, testing and control of products as well as pre-clinical and clinical development, Ensure compliance with U.S. and international regulations
May be accountable for management of personnel and their individual development to support achievement their professional quests as well as those of the Company
Other duties as assigned
Requirements Education and Experience
Minimum BS Degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Science, or a biological/biomedical discipline
An advanced degree (Masters, PhD) and RAC certification or equivalent are preferred
At least 10 years of relevant biopharmaceutical industry experience
Knowledge and Skills
Experience in a smaller, biotech company is a plus
Demonstrated leadership participation with U.S. and international submissions
Working knowledge of FDA and EMA regulations, pharmacopeial requirements, the regulators, the regulatory approval process
Excellent track record in building effective relationships with regulatory authorities
Proven ability to apply regulatory knowledge to various situations and serve as a source for the competitive advantage of the Company
Experience managing the assembly and messaging of all components of regulatory CMC submissions during development (e.g. IND, IMPD) and for marketing applications (e.g. NDA, MAA)
A strong record of successful submissions for drugs and peptides therapeutics which include INDs, IMPDs, NDAs, MAAs, Annual Reports, Amendments, Supplements, etc.
High degree of proficiency Microsoft Office Suite (i.e., Word, PowerPoint, etc.), Outlook Internet applications, WebEx, Zoom
High attention to detail and excellent proofreading and editing skills
Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion
Ability to multi-task, professional demeanor, strong attention to detail
Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude
Must be dependable; someone willing to go the extra-mile to get things done
Team player with excellent oral, written and verbal communication skills
VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
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Essential Duties and Responsibilities The main Regulatory Affairs responsibilities of this role include but are not limited to the following:
Develop regulatory intelligence as the basis for the formulation of efficient and effective CMC regulatory strategies with international scope
Implement developed regulatory strategies
Identify and implement tactics and positioning with other stakeholders (internal and external) to achieve the earliest possible approvals of all regulatory submissions
Represent the company as the primary regulatory CMC expert in corporate alliance team structures to facilitate the attainment of the corporate alliance objectives
Interact and negotiate with domestic and foreign regulatory agencies as the primary responsible party
Coordinate, draft, prepare and submit regulatory applications and documents
Take lead role in management of regulatory CMC activities for key projects and coordinate filing efforts between corporate disciplines
Identify and define key regulatory issues related to the manufacturing, testing and control of products as well as pre-clinical and clinical development, Ensure compliance with U.S. and international regulations
May be accountable for management of personnel and their individual development to support achievement their professional quests as well as those of the Company
Other duties as assigned
Requirements Education and Experience
Minimum BS Degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Science, or a biological/biomedical discipline
An advanced degree (Masters, PhD) and RAC certification or equivalent are preferred
At least 10 years of relevant biopharmaceutical industry experience
Knowledge and Skills
Experience in a smaller, biotech company is a plus
Demonstrated leadership participation with U.S. and international submissions
Working knowledge of FDA and EMA regulations, pharmacopeial requirements, the regulators, the regulatory approval process
Excellent track record in building effective relationships with regulatory authorities
Proven ability to apply regulatory knowledge to various situations and serve as a source for the competitive advantage of the Company
Experience managing the assembly and messaging of all components of regulatory CMC submissions during development (e.g. IND, IMPD) and for marketing applications (e.g. NDA, MAA)
A strong record of successful submissions for drugs and peptides therapeutics which include INDs, IMPDs, NDAs, MAAs, Annual Reports, Amendments, Supplements, etc.
High degree of proficiency Microsoft Office Suite (i.e., Word, PowerPoint, etc.), Outlook Internet applications, WebEx, Zoom
High attention to detail and excellent proofreading and editing skills
Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion
Ability to multi-task, professional demeanor, strong attention to detail
Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude
Must be dependable; someone willing to go the extra-mile to get things done
Team player with excellent oral, written and verbal communication skills
VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
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