1 DNA way South San Francisco, CA 94080
Bayside Solutions is seeking a Regulatory Associate to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- As appropriate, participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products
- As assigned, lead or otherwise participate in special projects and act as a standing or ad hoc member of other teams
- Lead Program Review Committees (PRCs) independently
- Demonstrate mastery of the review committee process and regulatory technical knowledge
- Are the decision-makers for the PRCs in their designated therapeutic or business area
- assignments; independently leading cross-functional PRCs and modeling strong facilitation and decision-making skills
- Represent client in official FDA communications and sign-off on 2253s
- Manage other departmental programs, projects and other deliverables with limited guidance from their managers
- Require limited direction to complete standard and non-standard work
- Can be relied upon for sound regulatory guidance and apply a strategic approach to problem-solving
- Effectively integrate regulatory, legal and commercial context and business knowledge to address complex problems
- Keep current in the areas of regulatory, healthcare compliance and ethics
- Proactively identify and address compliance issues
- Regularly lead cross-functional interactions, projects and teams
- Typically operate with a planning horizon of 6 – 12 months
Summary of Qualifications:
- Bachelor’ s degree (life sciences, law, public policy, marketing, business, education, or related discipline preferred)
- Graduate-level Degree strongly preferred (JD, MBA, MS, PharmD or other PhD, or related discipline)
- 7 or more years’ work experience in regulatory, legal, compliance, policy, auditing, training, communications or related disciplines in the bio/pharma industry
- Regulatory advertising and promotion experience strongly preferred
- Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal,
- clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.)
- Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, Values, Competencies and Leadership Commitments (where applicable)
- Strong influencing and negotiation skills: proven effectiveness leading diverse teams and influencing stakeholders of varying organizational levels without direct authority
- Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications
- Prepares well-researched and properly-toned emails in response to policy questions
- Has demonstrated consistent abilities to complete assignments with limited direction (over a period of time)
- Thinks “ outside the box” for solutions. Applies creative problem-solving and appropriate business solutions to effectively address compliance risk
- Excellent project management skills; can prioritize multiple tasks and goals to ensure timely, on-target and within budget accomplishment of such
- Demonstrates ability to identify appropriate resources. Exercises good judgment in terms of when to leverage internal resources
- Ability to travel (< 10%)